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Explore the details of each education track below to gain insight into how the ISPE Annual Meeting will solve your challenges.

Quality Systems

Track Director:

Rose Mary Dollard, Director, Regulatory Compliance, Johnson & Johnson

The Quality Systems sessions provide overviews of several key aspects of a robust quality management system (QMS) including practical solutions for implementation. Participants will get a better understanding of how to use a QMS as a business driver and flawless QMS integration within your organization's structure and processes.

Click on the SESSION TITLE below to view additional information

  • Operations-Focused Quality System Optimization Sunday, 12 October 13:00 - 15:00
  • These presentations provide tips for quality systems optimization with foucs on operations and supplier management.

  • How Good is Your Auditing System? Monday, 13 October 09:30 - 11:00
  • * Delegates will be able to benchmark their auditing system against 12 good auditing practices
    * The results will be captured and analysed during the session
    * Results from recent similar studies in Europe and the US will be presented for comparison
    * Potential solutions to the opportunities for improvement as identified from the delegates bench-marking scores will be discussed.

  • Quality Management Systems: A Guide to Monitoring End-to-End Product Health Monday, 13 October 09:30 - 11:00
  • This session will discuss utilizing Pharmaceutical Quality Systems and their enablers, Quality Risk Management and Knowledge Management, by providing:



    • Key areas of focus for PQS monitoring and management oversight

    • Effective strategies for PQS maintenance including change management


    FDA and Industry representatives will be available during the round-table discussion to provide current thinking on integration of risk management strategies and management's role within PQS. Ask questions about FDA's current thinking on updates to "A Quality Systems Approach to Pharmaceutical CGMP Regulations" guidance slated for update in FDA's current guidance agenda.

    • Leader: Paul D'Eramo, VP Pharma Regulatory Compliance, Johnson & Johnson, USA
    • Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
    • Georges France, Region Head Quality Europe, GSK-UK, Switzerland
      Detecting Quality Problems Before They Occur: Industry Perspectives on Risk-Based Quality Management Systems Approach
    • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
      FDA & Industry PQS Roundtable Disucssion- What Are Areas for PQS Advancement Post FDASIA?
    • Jean-Marie Geoffroy, Ph.D., VP Quality Pharma Engineering Team Lead Process Robustness, Hospira, a Pfizer owned company, USA
    • Claudia Lin, Ph.D., Director, QA, Global Biological Development, Bayer Healthcare, USA
      How to Use Different Quality System Elements for Product Management
  • Solutions for QbD and ASTM E2500 Implementation Monday, 13 October 12:30 - 14:30
  • This session provides practical solutions for implementation of Qbd concepts into your product development process and linkage of this data into the Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems.

  • Operational Excellence: Strategies for Readiness Monday, 13 October 15:30 - 17:30
  • This session details on how operational excellence and creating a state of readiness transforms companies into high-performance organizations.

  • Key elements of a Quality System Tuesday, 14 October 08:15 - 09:30
  • The QMS topics presented in this session relate to the need for easy accessibility to required documentation and effective Quality by Design practices.

  • Should All Quality Processes Move to the Cloud? Tuesday, 14 October 10:15 - 11:30
  • Life science companies are moving towards integrated models of individuals and partners around the world. This integration makes the management of many quality processes more complicated. This is compounded by evolving regulations and challenging business needs. These factors are driving companies to modernize their quality systems to meet the demands of an increasingly complex industry. Cloud applications break down many of the traditional geographical and logistical silos, enabling global collaboration and visibility. Cloud applications can be easy to get started and an attractive price point. Companies need to understand: Do the benefits outweigh the concerns? Should all quality processes move to the cloud? When to stay with a traditional quality system or postpone migrating to a new platform? What are the business risks introduced by the migration? This presentation will provide a roadmap from legacy to transformational processes using Cloud applications and will provide information on the following:
    œ Methodology and scorecard tool used to evaluate quality processes and their alignment to available quality systems
    œ Metrics for measuring the quantitative and qualitative benefits of a quality system
    œ Best practices on moving quality processes to cloud-based solutions and a framework for a migration plan
    œ Top challenges and concerns for quality processes including the impending changes in FDA regulations

  • Quality Culture & Continuous Improvement - Part I Tuesday, 14 October 13:00 - 14:30
  • This session deals with the development an effective and efficient organization by implementing a culture of quality and continuous improvement.

  • Quality Culture and Process Improvement - Part II Tuesday, 14 October 15:30 - 17:00
  • This session provides information for the use of quality metrics to track, trend, and manage the journey to fully engaged culture of quality and improvement in quality processes.

  • Translating Laboratory Developed Visible Residue Limits (VRL) to the Manufacturing Floor Wednesday, 15 October 08:00 - 09:15
  • Current industry knowledge related to establishing Visual Residue Limits (VRL) primarily focuses on the development of laboratory of limits based laboratory studies without holistically considering the integration of the visual inspection into the cleaning validation program. While considerable attention has been given to the development of Visual Residue Limits(VRL’s) in a laboratory setting, translating the bench scale values to the assessment of process surfaces has not yet been thoroughly assessed. This session provides insight intot the knowledge of the critical parameters that impact the determination of Visual Residue Limits and the influence of those parameters on visual inspection, can provide a framework for the development of a robust visual inspection program.

Manufacturing Technology

Track Director:

Michelle Gonzalez, BioPharm Engineering Consultant

This is a golden opportunity to participate in a comprehensive track exclusively developed for manufacturing professionals to learn about the latest advances in aseptic processing, containment, Blow-Fill-Seal, as well as single-use technologies. You will benefit from interactive and solution-focused sessions addressing QbD (Quality by Design), Operational Excellence and the special chance to attend the ISPE Critical Utilities Community of Practice (CU-CoP) overview session where you will be introduced to the latest changes to the ISPE Water and Steam C and Q Guide and participate in an in-depth synopsis of the upcoming ISPE Sampling Guide.

Click on the SESSION TITLE below to view additional information

  • Closure Processing: Container Integrity, Blow/Fill/Seal Sunday, 12 October 13:00 - 15:00
  • Process-based approaches for improving product yield in sterile drug product manufacturing: This topic proposes a systematic method for improving product yield in the processes of sterile drug product manufacturing. The method first aims to reduce product losses with considering the entire process: compounding, filling and visual inspection. The basis of the measurement and evaluation of various product losses according to the economic as well as quality severity to the company. This analysis enables prioritization of various causes of product loss that need attention for technical improvement. The second aim of the method is to adjust or possibly reduce the setpoint of the filling volume, which could result in the increase of product yield. Statistical methods can support determination of the adequate setpoint value of the filling volume, by considering the probability of underfilling/overfilling according to the specified setpoint. In both applications, understanding of the manufacturing process is incorporated as a critical mechanism to run the methods. This process-based approaches have been developed in a working group of more than ten pharmaceutical companies in ISPE Japan, for creating methods with wide applicability and for contributing to the realization of operational excellence in the industry.


    Particle Reduction during Component / Closure Processing: Maintaining a high level of quality for all primary product contact surfaces is critical, specifically for the final container and closure for injectable drug products. The container and closure must meet GMP requirements for sterility, endotoxin and particulate limits. This case study focuses on developing a component (closure) processing cycle that effectively reduces endotoxin and sterilizes the components, while minimizing particulate generation during the process. Developing an efficient processing cycle was especially challenging given the sometimes aggressive nature of the processing steps. Nevertheless, these components are required to be endotoxin and particulate free, sterile and must function smoothly on the filling line. Processing steps, such as washing, sterilization and drying, had to be carefully designed in order to meet the GMP requirements, while avoiding over processing which resulted in particle generation, damage to the components and potential improper function on the filling line.


    Utilizing Advanced Aseptic Blow/Fill/Seal packaging technology: Blow/Fill/Seal is an accepted and widely used packaging technology for many common pharmaceutical products including small and large injectable, inhalation and ophthalmic products. The plastic containers produced by the Advanced Aseptic BFS process have many advantages over conventionally filled glass containers. Some pharmaceutical and most biological products are sensitive to heat at some level. Exposure to a particular temperature for a certain time will cause product to deteriorate. Blow/Fill/Seal (BFS) is a packaging process that can add heat energy into the system. The BFS system has not been well quantized in regard to its thermal energy characteristics. This presentation will cover how BFS system as a hole was examined and its thermal energy characteristics were measured. This information was used to develop new systems that enable the BFS system to package heat sensitive products with minimal impact.


    Benchmarking Study of Container Closure Integrity for Sterile Products: Should pharmaceutical manufacturers implement 100% leak detection into sterile fill and finish operations? Container closure integrity (CCI) is critical to maintaining parenteral product stability and sterility. Defects in packaging components or out of control manufacturing processes result in CCI failures which in turn put product and ultimately patients at risk. Fully automated leak detection systems for monitoring CCI are now available that record data and provide insight into the number and type of package defects in individual batches. Lighthouse has analyzed batch CCI data from over 15 million vials manufactured by 4 large pharmaceutical companies, 2 from Europe and 2 from the USA. The data includes both liquid and lyophilized product manufactured over several years. The analysis shows that on average 0.6% of product show some type of container closure defect.

  • Manufacturing Reliability and Integrated Manufacturing Control Strategy Monday, 13 October 09:30 - 11:00

  • Integrated Manufacturing Control Strategy: Pharmaceutical manufacturers are experiencing challenges in regard to meeting the latest regulatory expectations in regard to demonstrating a risk based approach to the development of commercial manufacturing control strategies. In this highly regulated industry commercial manufacturing organizations struggle to optimize their processes. This presentation will illustrate an example of following a specific methodology to develop a process to design and execute an integrated manufacturing control strategy to achieve operational excellence. Leveraging a science and risk based approach throughout the product lifecycle and the process/product relationship for parenteral drug products. The process incorporates the concepts of the ISPE, PQLI Control Strategy model. The approach can be applied to implement both new and legacy products facilitated by the use of an electronic database management system.

  • Voltage Optimization: Energy Management & Sustainable Solutions Monday, 13 October 09:30 - 11:00
  • Over-voltage is supplied to a large number of US companies which causes increased energy consumption, high carbon emissions and premature equipment failure. The presentation will show how this can be corrected to reduce energy costs, reduce carbon emissions and reduce maintenance cost. Understand how high voltage levels affect your bottom line and take the opportunity to hear how green technologies can reduce your C02 emissions. See how other companies have saved energy and reduced costs.

  • Advanced Aseptic Processing - Part I Monday, 13 October 12:30 - 14:30
  • Learn from industry experts and experience in designing, qualifying and operating Barrier Isolator and Restricted Access Barrier Systtems (RABS) for aseptic processing. Understand how new technology is being utilized and leveraged for improved efficiency, compliance and cost effectiveness. Best practices and multi-national considerations will be shared through relevant case studies.
    "Explore best aseptic manufacturing practices and equipment for aseptic processing
    " Understand trends in industry and how industry is leveraging new technology
    "Learn from case studies on project management, qualification and operation of aseptic processing equipment and systems

  • Advanced Aseptic Processing - Part II Monday, 13 October 15:30 - 17:30
  • Learn from industry experts and experience in designing, qualifying and operating Barrier Isolator and Restricted Access Barrier Systtems (RABS) for aseptic processing. Understand how new technology is being utilized and leveraged for improved efficiency, compliance and cost effectiveness. Best practices and multi-national considerations will be shared through relevant case studies.
    "Explore best aseptic manufacturing practices and equipment for aseptic processing
    " Understand trends in industry and how industry is leveraging new technology
    "Learn from case studies on project management, qualification and operation of aseptic processing equipment and systems

  • Blow-Fill Seal Technology - Part I Tuesday, 14 October 08:15 - 09:30
  • The session will look at all aspects of blow-fill-seal technology and how it advances aseptic processing.
    " equipment design
    " container design
    " cleanroom environments suited for blow-fill-seal
    " case studies on production plants
    " case studies from end-users, i.e. production people
    " quality assurance and quality control aspects

  • Blow-Fill Seal Technology - Part II Tuesday, 14 October 10:15 - 11:30
  • The session will look at all aspects of blow-fill-seal technology and how it advances aseptic processing.
    " equipment design
    " container design
    " cleanroom environments suited for blow-fill-seal
    " case studies on production plants
    " case studies from end-users, i.e. production people
    " quality assurance and quality control aspects

  • Single-Use Technology can give you a fast moving scale-up of your process - but did you miss anything in the frenzy? - Part I Tuesday, 14 October 13:00 - 14:30
  • Scale-Up of Single-Use Technology can present unique situations that require an early strategy to prevent derailement of project plans. Ensuring a smooth transition into clinical and commercial production is critical for successful start-ups. As Single-Use products are applied more consistently in production scale operations, new methods that are effective and streamlined are critical for this success. The growth of Single-Use technology continues to advance into production processes. This fast growth accentuates factors for a smooth implementation of this flexible technology in a structured and regulated environment. These important factors are getting addressed with heightened sensitivity as Single-Use products that satisfy regulatory requirements are rapidly introduced into operations. Factors such as integrity of disposables, operational performance reliability, and robust supply chain, xtractables/leachables, particulate control, and operational methods represent areas that can benefit from applying practical solutions without raising complexity. This educational session highlights techniques and case studies that have been helpful in addressing these challenges. The session also provides an update on the development and publication of ISPE's Good Practice Guide for Single-Use Technology.

    • Leader: Pietro Perrone, PE, Mobius Single-Use Sys Eng, EMD Millipore Corporation, USA
      Best Practices for Single-Use Technologies
    • Kate Lee, Process Development Engineer, USA
      Lost in Translation: Dealing with Raw Material Changes for Single-Use in Cell Culture Application
    • Roman Rodriguez, Global Market Development Manager, EMD Millipore, USA
      Single-Use Technologies: Opportunities and Challenges...
    • David Wolton, Biopharma Consultant, PM Group, Ireland
      Next Generation Hybrid Facilities-Introducing the Dance Floor Concept
  • Blow-Fill Seal Technology - Part III Tuesday, 14 October 13:00 - 14:30
  • The session will look at all aspects of blow-fill-seal technology and how it advances aseptic processing.
    " equipment design
    " container design
    " cleanroom environments suited for blow-fill-seal
    " case studies on production plants
    " case studies from end-users, i.e. production people
    " quality assurance and quality control aspects

  • Single-Use Technology can give you a fast moving scale-up of your process - but did you miss anything in the frenzy? - Part II Tuesday, 14 October 15:30 - 17:00
  • Scale-Up of Single-Use Technology can present unique situations that require an early strategy to prevent derailement of project plans. Ensuring a smooth transition into clinical and commercial production is critical for successful start-ups. As Single-Use products are applied more consistently in production scale operations, new methods that are effective and streamlined are critical for this success. The growth of Single-Use technology continues to advance into production processes. This fast growth accentuates factors for a smooth implementation of this flexible technology in a structured and regulated environment. These important factors are getting addressed with heightened sensitivity as Single-Use products that satisfy regulatory requirements are rapidly introduced into operations. Factors such as integrity of disposables, operational performance reliability, and robust supply chain, xtractables/leachables, particulate control, and operational methods represent areas that can benefit from applying practical solutions without raising complexity. This educational session highlights techniques and case studies that have been helpful in addressing these challenges. The session also provides an update on the development and publication of ISPE's Good Practice Guide for Single-Use Technology.

  • Containment of Potent Compounds - Technology & Design Best Practices & Lessons Learned Tuesday, 14 October 15:30 - 18:00
  • This session will focus on the containment of potent compound associated with the manufacturing of pharmaceutical and biologic products. This informative session will cover all aspects of containment technology and facility design, from Airflow Techniques, Barrier Isolation, and Disposable Technology associated with API and OSD. The session will demonstrate through Case-Studies, Industry Design Practices, and Lessons Learned how a contained and controlled process is beneficial with regards to product quality, cost-of-goods, and environmental exposure.

    Integration Strategy - Potent Compound Technology & Facility Design
    Containment Strategy/Philosophy
    Influential Design Factors
    Control Zone(s) - Define & Identify
    Layout Configuration
    Levels of Separation
    Material/Process/Personnel Logistics
    Containment Technology & Integration

  • Critical Utilities COP Overview - Part I Wednesday, 15 October 08:00 - 09:15
  • This session will begin with an overview of available CU COP publications and their content and how these publications provide information to improve/enhance design and help optimize the operation of water, steam, and compressed gas systems. The inner workings of the CU COP and available volunteer opportunities would be discussed during the session to help improve volunteer involvement within the COP. The first part of the session would finish with a round table discussion of content that is currently unavailable in the marketplace and how the CU COP could create content to bridge the gap. The second part of the session would include an in-depth overview of the new Sampling Guide. This would include a content overview, discussion of hot/controversial topics found within the Sampling Guide, and how the sampling Guide could be used by attendees within their position. The third part of the session would include an overview of the updated Water and Steam C&Q Guide. This would include a content overview, discussion on the major changes within the publication, and how the C&Q Guide may be used by attendees in their position. The session would conclude with an invitation to attend a Pharma Utilities Users Group that would be open to individuals that work directly for a pharmaceutical/medical device company. At this meeting, we would have a round table discussion for attendees to openly discuss and troubleshoot issues that they are currently having on their utility systems.

  • Critical Utilities COP Overview - Part II Wednesday, 15 October 11:00 - 13:00
  • This session will begin with an overview of available CU COP publications and their content and how these publications provide information to improve/enhance design and help optimize the operation of water, steam, and compressed gas systems. The inner workings of the CU COP and available volunteer opportunities would be discussed during the session to help improve volunteer involvement within the COP. The first part of the session would finish with a round table discussion of content that is currently unavailable in the marketplace and how the CU COP could create content to bridge the gap. The second part of the session would include an in-depth overview of the new Sampling Guide. This would include a content overview, discussion of hot/controversial topics found within the Sampling Guide, and how the sampling Guide could be used by attendees within their position. The third part of the session would include an overview of the updated Water and Steam C&Q Guide. This would include a content overview, discussion on the major changes within the publication, and how the C&Q Guide may be used by attendees in their position. The session would conclude with an invitation to attend a Pharma Utilities Users Group that would be open to individuals that work directly for a pharmaceutical/medical device company. At this meeting, we would have a round table discussion for attendees to openly discuss and troubleshoot issues that they are currently having on their utility systems.

  • Cleaning Validation: IMP Products, Bio Facility, Quantitative Image Processing Wednesday, 15 October 11:00 - 13:00
  • Cleaning Validation: Developing cleaning programs based on the premise of intact active biopharmaceutical products carrying over into the next batch is an inappropriate approach that results in an inflexible cleaning program with overdeveloped cleaning cycles and artificially high cleaning validation acceptance limits. Drawing on principles laid out in ISPE’s Risk MaPP guideline as well as other industry guidance documents, this pitfall can be easily avoided by conducting well designed bench scale developmental cleaning studies that support principle strategic elements of the cleaning program. Further, by employing Design of Experiments methodologies as recommended by the FDA Process Validation Guideline, quantitative information can be collected for the determination of appropriate cleaning agent formulations, comparisons of multiple post production residues, and initial time, temperature, external energy, and concentration parameters for the development of full scale manufacturing cleaning cycles. This presentation will describe the methodologies manufacturers can use for the development of a robust, data-driven cleaning program.


    Reduce Cleaning Validation for IMP: Recognizing the need for increased production capability and continuous improvement, Genentech directed a task force, the Strike Team, to identify and make improvements in the area of cleaning validation. Following extensive review of cleaning validation practices, the team identified molecules where significant benefit could be achieved from reduced testing with moderate effort. Specifically, the team identified the equipment and cleaning systems used for producing early stage clinical molecules (IMP) and the equipment used to manufacture them. In order to achieve this, a unique team environment was created where a small group of technology experts focused on the area of cleaning validation for 6 months, full-time. The team was co-located and utilized project management and traditional Operational Excellence tools such as DMAIC and non-traditional (e.g. agile methods from the software industry). The team didn't focus on day-to-day manufacturing challenges but rather how to make fundamental changes to the cleaning program and how we look at cleaning of early stage molecules. In order to solve this problem the team leveraged historical experience (concurrent cleaning validation data, reliability of the CIP systems, and molecule attributes) and used a risk based approach to justify reduced testing providing a cost savings of 550 FTE hours per Phase I/II campaign.


    Quantitative Image Processing for Cleaning Validation and Verification Activities: Visual inspection is a powerful tool for cleaning validation and verification activities that allows for the detection of contaminants concentrated in small areas that could otherwise go undetected by surface sampling or other analyses. However, the accuracy and repeatability in the results from this visual inspection may depend significantly on the experience and level of training of the individual performing the inspection, as well as the quality of their vision. This novel image processing method is an analytical technique that allows for a quantitative assessment of the concentration of process residue on equipment, and this method has already been demonstrated to have a minimal dependence on the operator while still providing adequate accuracy, linearity, and repeatability at the bench scale.

Global Regulatory and Compliance

Track Director:

Steve Tyler, Director, Quality Assurance, AbbVie

Participants in these sessions will gain a new level of understanding and clarity about proactive approaches to compliance in a global environment. Revealing case studies, regulatory perspectives and insights from industry leaders will prepare participants to take positive action within your company.

Click on the SESSION TITLE below to view additional information

  • Developments in Global Harmonization Sunday, 12 October 13:00 - 15:00
  • Qualifying a manufacturing facility in China to comply with EU and US GMP guidelines:

    Previously very few pharmaceutical manufacturers in China have aimed to launch their products in EU or the US. Only API manufacturers have been exporting internationally. But this case study presents a case where a new facility for a biosimilar product has been built and qualified with state-of-the-art risk management methods to US and EU standards, probably for the first time. There have been a number of technical and cultural challenges that are beneficial for the audience. Undoubtedly there will be a number of Chinese companies seeking to register their products internationally over the coming years. This presentation will facilitate a better understanding of the unique challenges and the many opportunities that this export drive will bring.

    Mass Serialization and Track & Trace Implementation:

    The presentation will address questions about how to implement Track & Trace system, which is currently a hot topic for many countries. The infrastructure, whole project framework including planning, design, implementation, testing and monitoring will be presented. Qualification strategies, integration with internal ERP system as well as with Ministry of Health's database will be covered.

    Helping Companies Achieve PIC/S Regulatory Standards in ASEAN Region:

    This presentation supports Best Practices for Operational Excellence by showing how SMEs in the ASEAN Region can achieve PIC/S International Standards using tried and tested tools and existing documents including ISPE publications. There are important quality issues which affect many SME companies in ASEAN region who are trying to reach PIC/S regulatory standard. Getting the companies to understand the importance of an effective quality management system is an important step on the road to fixing the problem. This presentation provides practical examples of setting up a quality management systems and establishing methods for annual product review.

  • Risk - Part I Sunday, 12 October 13:00 - 15:00
  • What is H.R. 3204?

    Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly make its way back to a global dilemma: safeguarding the public from counterfeit drugs. Now that H.R. 3204 • Drug Quality and Security Act (DQSA) is law, US-based prescription drug manufacturers must be able to verify the authenticity, identity and whereabouts of their drug products from manufacturing through distribution supply chains. No easy task to be sure, but the law is a call for action. Find out what this law means to you, your firm, and authorized trading partners. In addition, find out how the market is reacting to address this federal mandate on pharmaceutical track and trace requirements.

    Solutions and Approaches to the Drug Quality and Security Act:

    The efforts around anti-counterfeiting are only escalating in the US. The passage of the DQSA represents a 10 year odyssey of discussion between industry and government. This presentation will discuss the framework for defining and implementing serialization technology along with considerations for the global marketplace and will discuss the timeline for DQSA deployment and the latest thinking from the big three wholesalers in the US that will dramatically impact pharma manufacturers.

    Case Study: Sproxil

    Antimalarial drugs, which are vital in countries like Nigeria, are often targeted by thieves and counterfeiters and sold to unknowing consumers for notable profit. After Nigeria’s National Agency for Food & Drug Administration and Control (NAFDAC) repeatedly intercepted fake antimalarial LONART DS drugs, manufacturer Bliss GVS Limited (India) and distributor Greenlife Pharmaceuticals (Nigeria) partnered with brand protection specialist Sproxil to secure their flagship product.

  • C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline - Part I Monday, 13 October 09:30 - 11:00
  • C&Q: Fulfilling stage 2A of the FDA Process Validation Guideline - Stage 2A overview, example case studies and industry benchmarking
    The FDA guidance for industry on process validation published in January 2011 defines the specification, design, and qualification of the facility, equipment and utilities as stage 2A, of the three stage process validation effort. Stage 2A supports Stage 2B, process performance qualification (PPQ). The Verification/C&Q of the manufacturing systems is intended to address the critical aspects (CA) of the manufacturing process control strategy associated with the CQAs and CPPs identified in stage 1.
    The Quality Risk Management (QRM) approach to C&Q, as defined in ASTM E-2500 and the associated ISPE guidance documents provide approaches and best practices to meet the regulatory expectations and requirements for stage 2A. However companies are still challenged during the implementation of a science and risk-based approach with the relationship of QRM C&Q process validation not being fully understood.
    " Requirements definition to support manufacturing system design
    " Application of Quality Risk Management throughout the manufacturing system lifecycle
    " Verification of manufacturing systems to assure fit-for-intended use
    " Manufacturing system release for use and maintaining the validated state
    " Case Study examples and Industry benchmarking

  • Risk - Part II Monday, 13 October 09:30 - 11:00
  • Regulatory Requirements for GCP systems - A Global View:

    The increase of international clinical trials performed around the world and the growing number of countries participating to the different phases of the trial process is leading to a more and more complex situation which has to be managed in an efficient and cost saving way. One of the major challenges is to stay compliant with the various GCP requirements in place and to keep current with newly released and/or modified requirements for GCP related computerized systems to defend them in sponsor audits and/or regulatory inspections. This is especially important because in comparison with other GxP areas (e.g. GLP & GMP) it is more difficult for the regulatory inspectors to verify GCP compliance of the systems based on the available local legal requirements. This presentation will provide an up to date overview about the GCP related system validation regulations and guidance within the three ICH regions (USA, EU & Japan) and compares them with regulations and guidance released outside of this area by other countries participating in today’s clinical trial process. In addition this presentation will summarize available information about GCP system validation related audit and inspection findings. Such a current overview and the related audit & inspection trends will support enhanced GCP compliance on system level for international clinical trials.

    Handling Regulatory GMP Inspections:

    This presentation provides a wide range of suggestions and tips on how to handle all stages of a regulatory GMP inspection, covering before, during and after the inspection. The presentation also includes important “Do’s and Don’ts” for the handling of regulatory inspections as well as the key secrets on how to be successful with regulatory inspections.

  • Managing Assets and Equipment for Reliable Drug Supply Monday, 13 October 09:30 - 11:00
  • Due to ongoing drug shortage events reported to FDA and the associated risk to patients, the Agency has been analyzing all facets of reliably delivering pharmaceutical products to the public. This session will focus on best practices to avoid or mitigate shortages and continued development of risk-based approaches to identify early warning signals for manufacturing and quality problems to prevent supply disruptions. We will address the regulatory and technological challenges that you and your vendor must consider when implementing Reliability Engineering based support of physical assets including automation equipment, production equipment, process control and process monitoring equipment through third party vendors.

  • C&Q: Fulfilling Stage 2A of the FDA Process Validation Guideline - Part II Monday, 13 October 12:30 - 14:30
  • C&Q COP: Fulfilling Stage 2A of the FDA Process Validation Guideline - Stage 2A overview, example case studies and industry benchmarking
    The FDA guidance for industry on process validation published in January 2011 defines the specification, design, and qualification of the facility, equipment and utilities as stage 2A, of the three stage process validation effort. Stage 2A supports Stage 2B, process performance qualification (PPQ). The Verification/C&Q of the manufacturing systems is intended to address the critical aspects (CA) of the manufacturing process control strategy associated with the CQAs and CPPs identified in stage 1.
    The Quality Risk Management (QRM) approach to C&Q, as defined in ASTM E-2500 and the associated ISPE guidance documents provide approaches and best practices to meet the regulatory expectations and requirements for stage 2A. However companies are still challenged during the implementation of a science and risk-based approach with the relationship of QRM C&Q process validation not being fully understood.
    " Requirements definition to support manufacturing system design
    " Application of Quality Risk Management throughout the manufacturing system lifecycle
    " Verification of manufacturing systems to assure fit-for-intended use
    " Manufacturing system release for use and maintaining the validated state
    " Case Study examples and Industry benchmarking

  • Modeling within the QbD Framework & Lifecycle Considerations - Part I Monday, 13 October 12:30 - 14:30
  • In order to understand the impact of variations within the product lifecycle, whether in product development or manufacture, developers and manufactururers need to:
    - understand the variations in the processes
    - understand the cause of the variations
    - understand how to control the process within the limitations of the design space
    Modelling of the process, in both development and manufacture, provides an understanding of the impact of those variations, whether in the materials or the manufacturing process, and the opportunity to minimize and control the variability of the finished product.

  • Symposium on Process Capability: A Leading Quality Metric? Monday, 13 October 15:30 - 17:30
  • Due to the lack of quantitative metrics, pharmaceutical scientists often face these challenging questions: "Is my product quality increasing, declining or constant?" "Which manufacturing sites or product classes are at higher risk of failure?" "What are the continual improvement opportunities for my current process -to reduce variability, to adjust the process mean, or fundamentally re-design the process in order to meet customer needs (specifications)?". Even though process capability indices have been used by other industries to measure and improve process performance since 1956, its use in pharmaceutical industry is limited.
    1. Performance based Regulation- A New Era
    2. Use process capability to ensure pharmaceutical product quality
    3. Brand industry perspective on
    4. Generic Industry perspective
    This symposium will serve as an open forum to discuss the potential utility of the process capability in ensuring pharmaceutical product quality: the regulatory perspective, current industry practice, benefits, challenges, and more.

  • Modeling within the QbD Framework & Lifecycle Considerations - Part II Monday, 13 October 15:30 - 17:30
  • In order to understand the impact of variations within the product lifecycle, whether in product development or manufacture, developers and manufactururers need to:
    - understand the variations in the processes
    - understand the cause of the variations
    - understand how to control the process within the limitations of the design space
    Modelling of the process, in both development and manufacture, provides an understanding of the impact of those variations, whether in the materials or the manufacturing process, and the opportunity to minimize and control the variability of the finished product.

  • Addressing Challenges in Implementation of the Lifecycle Approach to PV - Part I Tuesday, 14 October 08:15 - 09:30
  • ISPE PQLI PV Team progress with fostering practical implementation of the lifecycle approach to PV will be reviewed, including available aide documents. Plans for future deliverables will also be reviewed, including conferences and training. Application of the lifecycle PV approach to legacy products including challenges and recommendations included in the upcoming ISPE PV Team discussion paper will be presented. Applying lifecycle approach at contract manufacturers can be especially tricky and recommendations to assure full compliance and smooth communication of throughout the lifecycle will be reviewed. This presentation will be based on ISPE PV team discussion paper which will be available by end of year.

  • BIO-QbD - Part I Tuesday, 14 October 08:15 - 09:30
  • Element of QbD: Process Modelling, Robustness and Human Factors: As complexity of a process and measurement increases, so does the need for sophisticated and comprehensive techniques to define a design space and control strategy. The limited data available from development and Process Performance Qualification (PPQ) warrants modelling approaches that leverage all available data. Also, robustness monitoring in the ongoing monitoring stage (CPV) stage can be used to refine the control strategy developed with this sparse data. Are there other elements that improve the outcome? Indeed, there is an element to QbD that is often overlooked - the potential impact of human interaction with a process, and the use of standardized work to reduce this risk. Practitioners who recognize and apply best practices to address all elements will develop a more robust process, and lead more successful continuous improvement efforts.

  • Addressing Challenges in Implementation of the Lifecycle Approach to PV - Part II Tuesday, 14 October 10:15 - 11:30
  • Two of the most significant challenges with implementation of the lifecycle approach to PV include determination of an appropriate number of batches and a (heightened) monitoring plan just following process performance qualification. A review of the compliant approaches included in the ISPE PV Team discussion paper for determination of the number of batches for PPQ and planned additional discussion paper including more alternative approaches, some discussed at the 2014 ISPE Statistics in PV Forum, will be explained. A real case study in application of PV stage 3a expectations will also be presented and will help to crystallize some of the associated concepts for those having not yet fully implemented a PV stage 3a program.

    • Leader: Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co, USA
    • Leader: Jennifer Walsh, Director Robustness & Validation, Bristol-Myers Squibb, USA
    • David Dolgin, Senior Validation Consultant, BioTechnique, USA
      Implementation of PV Stage 3a - A Practical Case Study
    • Yanhui Hu, Ph.D., Principal QA Project Mgr, AbbVie Inc, USA
      ISPE Discussion Paper Topic 1 – Process Validation Stage 2: Determining and Justifying the Number of Process Performance Qualification Batches
  • BIO-QbD - Part II Tuesday, 14 October 10:15 - 11:30
  • Application of the Lifecycle Approach to PV to Continuous Manufacturing and FDA Perspective of Lifecycle Approach to PV Implementation Progress Tuesday, 14 October 13:00 - 14:30
  • Continuous manufacturing is of great interest to both pharma manufacturing and pharma regulatory personnel, as it potentially offers both significant efficiency and assurance of quality gains. With the implementation of continuous manufacturing, comes questions about how the lifecycle approach to PV can be applied. The opening presentation will leverage work completed as part of an FDA/MIT initiative and will complement sessions on continuous manufacturing to be held the following day. This will be followed by a presentation by the FDA regarding their perspective of progress with implementation of the lifecycle approach to PV.

  • Drug Shortages Tuesday, 14 October 13:00 - 14:30

  • Problem or Opportunity Statement:

    If you think drug shortages is a company problem reserved for your CEO, VP of Quality, doctors, pharmacists or patients, you are wrong and your attendance at this session is essential. Really.

    Since launching ISPE's Drug Shortages Initiative in 2012, hundreds of ISPE Members, members of other associations, regulators and government leaders have been a part of a global journey that began with a survey to determine the root causes of drug shortages. Based on that groundbreaking 2013 survey, ISPE has developed a comprehensive organizational Drug Shortages Prevention Plan-a roadmap describing how every employee, every leader and every organizational function impacts successful outcomes, preventing drug shortages.

    ISPE's new Drug Shortages Prevention Plan will be presented for the first time in this session. Hear directly from the Plan's creators as well as other session presentations describing case studies on drug shortage prevention and practical experiences.


    Learning Objectives:


    • Learn in this session how ISPE's Drug Shortages Prevention Plan guides companies to more contemporary systems, and healthier organizational cultures as well as approaches to communication, training and capacity building.

    • Understand how more effective alignment of governance, management and controls, and the quality system with good manufacturing practices, practical business and continuity planning measurements and metrics lead to organizational success and the prevention of drug shortages.

    • Hear how companies have successfully implemented a pharmaceutical quality system across global supply chains and how that success directly avoided or alleviated a drug shortage.

    • Understand how to evolve process elements and knowledge management associated with CAPA, deviation management, risk assessments, product realization, and process optimization to avoid shortages.

    • Every Member, every employee, needs to know.

    • Leader: Paul D'Eramo, VP Pharma Regulatory Compliance, Johnson & Johnson, USA
    • Leader: Stephen Mahoney, JD, Senior Director, Global Quality & Compliance, Genentech/Roche Inc, USA
    • John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., United Kingdom
    • Mark Birse, Group Manager Inspectorate, MHRA, United Kingdom
      MHRA Update on Expectations for PV for EU
    • Brendan Cuddy, Head of Service, EMA, United Kingdom
      EMA Initiatives on Drug Shortages
    • Donna Gulbinski, Sr VP, Global Quality & EHS, Bristol-Myers Squibb Co, USA
      International Launch of the ISPE Drug Shortage Prevention Plan
    • Douglas Throckmorton, MD, Deputy Center Director for Regulatory Programs, FDA/CDER, USA
      FDA Update on Drug Shortages
  • Metrics Tuesday, 14 October 15:30 - 18:00
  • This session will provide a comprehensive update of quality metrics programs designed to support the FDA initiative required by FDASIA. FDA has been invited to give the status of their thinking and perspective on quality metrics. Diane Hagerty, Vice President, Quality System & Processes, Roche/Genentech and lead for the ISPE Quality Metrics Project team will provide the latest information on the status of the ISPE Quality Metrics Pilot program launched at the beginning of June 2014. Speakers have been invited to provide an update on other complementary quality metrics programs such as the PDA survey on quality culture and the Xavier University quality metrics program. Time has been allocated for a Panel discussion of all speakers chaired by Joe Famulare, Vice President, Global Compliance and External Collaboration, Roche/Genentech.

    • Leader: Joseph Famulare, VP, Global Compliance and External Collaboration, Pharma Technical Quality, Genentech/Roche, USA
    • Laura Cannon, Sr. Director, Quality, Teva Pharmaceuticals, USA
      FDA / Xavier Quality Metrics Perspective
    • Dee Carri, MSc, Founder & Director, Torque Management Limited, Ireland
    • Diane Hagerty, Vice President, Genentech Inc, USA
      Update on the PQLI Quality Metrics Pilot
    • Steven Mendivil, Sr. Advisor International Quality, Amgen Inc, USA
      PDA Perspective and Update on Quality Culture
    • Russell Wesdyk, OPS Scientific Coordinator, FDA/CDER/OPS/IO, USA
      FDA Quality Metrics Initiative
  • Lifecycle Approach to PV Stage 3a and 3b - Case Studies Tuesday, 14 October 15:30 - 17:00
  • Application of the Lifecycle Approach to PV to biologics can present unique challenges due to the heterogeneous nature and number of inputs to the manufacturing process. A real case study explaining considerations in the development of heightened monitoring plan for a biologic product will be shared. Lifecycle approach to PV also emphasizes expectation for statistical basis for routine sampling and testing program. A real case study for risk and statistically based PV stage 3b plan will be presented. Session will conclude with a panel discussion of challenges and recommendations for PV stage 3a and 3b.

  • Continuous Manufacturing - Part I Wednesday, 15 October 08:00 - 09:15
  • Continuous Manufacturing is gaining ground in the Pharmaceutical Industry. According to recent presentations from regulatory agencies, at least 8 companies are looking into continuous manufacturing with more coming on board. Continuous Unit operations have been adopted both for Drug Substance and Drug Product Manufacturing.

    • Leader: Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs, ISPE, USA
    • Leader: Rapti Madurawe, PhD, Division Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ/OPF, USA
      Regulatory Perspective on Continuous Manufacturing
    • Yanxi Cain, PhD, Executive Director, Global Quality Assurance, Merck, USA
      Continuous Manufacturing at Novartis - Why continuous?
    • Jennifer Schubert, Vertex Pharmaceuticals, USA
      Continuous Manufacturing at Vertex - reasoning PAT & Automation
  • Latin American Regulatory Compliance - Part I Wednesday, 15 October 08:00 - 09:15
  • Emerging markets within its landscape, the Latin America region becomes a rapidly growing market for pharmaceutical products, health authorities in these countries have been actively strengthening their regulations and guidelines. Multinational companies (MNCs) who import their products into Latin America countries for drug development or marketing are facing an increasingly complex regulatory environment. This session will provide an overview of the ever changing regulatory landscape in the region in several areas: Stability Testing Requirements; Local Testing and acceptance of Waivers, Lean stability approaches and case study results in Brazil and Mexico. Progress of any ongoing regulatory harmonization or convergence efforts on CMC (chemistry, manufacturing, and controls) and GMP will be reported. Trends for regulatory divergence or country-specific requirements will be analyzed. Hot topics on regulations and guidelines in key countries will be discussed including challenges and opportunities for multi-national companies.

  • Global Expectations for Process Validation Wednesday, 15 October 08:00 - 09:15
  • An EMA Regulator will review validation expectations in Europe, including some of the changes being considered. ISPE PV Team representatives will review some of the most significant and frequent comments received from ISPE members in regard to the draft Annex 15. This will be followed by a questions and answers session on global validation expectations.

  • Continuous Manufacturing - Part II Wednesday, 15 October 11:00 - 13:00
  • Continuous Manufacturing is gaining ground in the Pharmaceutical Industry. According to recent presentations from regulatory agencies, at least 8 companies are looking into continuous manufacturing with more coming on board. Continuous Unit operations have been adopted both for Drug Substance and Drug Product Manufacturing.

  • Latin American Regulatory Compliance - Part II Wednesday, 15 October 11:00 - 13:00
  • Emerging markets within its landscape, the Latin America region becomes a rapidly growing market for pharmaceutical products, health authorities in these countries have been actively strengthening their regulations and guidelines. Multinational companies (MNCs) who import their products into Latin America countries for drug development or marketing are facing an increasingly complex regulatory environment. This session will provide an overview of the ever changing regulatory landscape in the region in several areas: Stability Testing Requirements; Local Testing and acceptance of Waivers, Lean stability approaches and case study results in Brazil and Mexico. Progress of any ongoing regulatory harmonization or convergence efforts on CMC (chemistry, manufacturing, and controls) and GMP will be reported. Trends for regulatory divergence or country-specific requirements will be analyzed. Hot topics on regulations and guidelines in key countries will be discussed including challenges and opportunities for multi-national companies.

    • Leader: Maria Jacobs, Ph.D., Director Quality Intelligence, Pfizer Inc, USA
    • Leader: Ivone Takenaka, Ph.D., Associate Director, Regulatory CMC, Bristol-Myers Squibb Co., USA
      Post Approval Changes - Global overview and current regulatory trends in Latin America - an industry perspective
    • Stephen Colgan, Ph.D., Senior Director in Global CMC, Pfizer Global Research and Dev, USA
      Implementation of Lean Stability Strategies in Latin America

Information Systems

Track Director:

Randy Perez, Ph.D., Director, Info Governance-Management, Novartis Pharmaceuticals

The Information Systems track includes information, discussions and workshop activities on a variety of aspects important to the management, documentation and compliance of the business of healthcare companies. We feature multiple sessions on today™'s important topics of data integrity and serialization. In addition, delegates will have an opportunity to learn about some of the work being done within ISPE relating to the adoption and management of leading-edge technologies such as the use of mobile and cloud computing. Also of interest are a range of IT and automation-related topics as varied as maintaining control of your computerized systems, the paperless laboratory, agile software development of GxP applications, GxP IT infrastructure and decommissioning a regulated system. Delegates who attend sessions within this track will improve their understanding of the controls and requirements associated with implementing, managing and retiring applications and data within the regulated environment.

Click on the SESSION TITLE below to view additional information

  • Models for IT Infrastructures and Agile Development Monday, 13 October 09:30 - 11:00
  • Applying the GAMP V-model to Agile Development

    The pharma and biotech industry currently struggles with applying the traditional V-model and GAMP concepts to the current trend of Agile Development. This presentation shall demonstrate how to apply traditional computer systems validation and SDLC deliverables to the Agile methodology in a practical and efficient manner. Agile Development is a current trend within Information Technology (IT/IS) for delivering the operational excellence and best practices of IT systems within the pharma/biotech/CRO industry. It allows for quicker roll-out/implementation of IT systems in an interative manner, thus providing quicker realized benefits to the business units those systems support. This presentation will demonstrate how this can be achieved while still maintaining compliance and control through following GAMP 5.

    • Leader: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA
      Applying the GAMP V-model to Agile Development
    • Daniel Montgomery, Manager, IT Quality, Covance Inc, USA
  • Data Integrity - Part I Monday, 13 October 12:30 - 14:30
  • Data integrity surrounding computer system supported business processes has been at the forefront of recent news e.g., Ranbaxy and Obama Care, and the awareness of these issues has changed the approach used by regulators in conducting inspections in recent years. As data integrity has become the focus of regulatory inspections, the industry has to recognize and ensure controls for data integrity are implemented and appropriately managed throughout the data's entire lifecycle. Problems with data integrity manifest themselves differently in each phase of the lifecycle. Therefore improvements must be managed differently during each phase. Industry must change because -
    o Industry has gone to increased use of computer systems for efficiency gains.
    o Software with advanced capabilities for capture and review of data history.
    o Regulatory agencies have learned to review data leading to changes in how they conduct inspections
    Industry needs to learn how to establish controls to identify data integrity issues in process. While focusing on the identification of issues is important it is just as important to focus on identification of pragmatic approaches and mitigation strategies.

    • Leader: Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly & Co, USA
    • Leader: Lorrie Vuolo-Schuessler, Manager, Computer Systems Quality Assurance, GlaxoSmithKline, USA
    • Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
      Risk Assessment and Management of the Data Life Cycle
    • Mark Newton, Associate Senior Consultant QA, Eli Lilly & Co, USA
      Workshop Introduction - Process and Data Flows
  • Data Integrity - Part II Monday, 13 October 15:30 - 17:30
  • Data integrity surrounding computer system supported business processes has been at the forefront of recent news e.g., Ranbaxy and Obama Care, and the awareness of these issues has changed the approach used by regulators in conducting inspections in recent years. As data integrity has become the focus of regulatory inspections, the industry has to recognize and ensure controls for data integrity are implemented and appropriately managed throughout the data's entire lifecycle. Problems with data integrity manifest themselves differently in each phase of the lifecycle. Therefore improvements must be managed differently during each phase. Industry must change because -
    o Industry has gone to increased use of computer systems for efficiency gains.
    o Software with advanced capabilities for capture and review of data history.
    o Regulatory agencies have learned to review data leading to changes in how they conduct inspections
    Industry needs to learn how to establish controls to identify data integrity issues in process. While focusing on the identification of issues is important it is just as important to focus on identification of pragmatic approaches and mitigation strategies.

    • Leader: Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly & Co, USA
    • Leader: Lorrie Vuolo-Schuessler, Manager, Computer Systems Quality Assurance, GlaxoSmithKline, USA
    • Moderator: James Eichelman, President & Principal Consultant , James Eichelman and Associates, LLC, USA
      Lab Workshop – Development of process/ data flows
    • Moderator: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
      Planning and Implementation of GxP Relevant IT Infrastructures
    • Moderator: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA
      Clinical Workshop – Development of process/ data flows
    • Moderator: Christopher White, Associate Director, E-Quality Systems, Alexion Pharmaceuticals, USA
      Lab Workshop- Development of process/data flows
    • Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
      Roundtable Q & A
    • Orlando Lopez, E-records Integrity SME, USA
      Roundtable Q & A
    • Chinmoy Roy, Biopharmaceutical Consultant, Self Employed, USA
      Roundtable Q & A
    • Karen Takahashi, Senior Policy Advisor, FDA/CDER/OPQ/OPPQ/DRGS/CO, USA
      Non-Electronic Ways of Verifying the Authenticity of Data
      Roundtable Q & A
  • Current Status and Trends on Serialization and Track&Trace Part I Tuesday, 14 October 08:15 - 09:30
  • - Reasons and motivation that caused the increase of the importance of serialization and T&T Worldwide
    - Current status and tendencies on serialization and T&T in the World - existent and future regulations and their differences and similarities. How fast the suppliers and the industry are advancing by their side and preparing themselves (short, mid and long term expectations)
    - Technologies and technical aspects for serialization and T&T - currently available and trends
    - Case studies and practical examples on serialization and T&T implementation, operation and maintenance
    Interfaces of serialization and T&T with other management and technical areas

    • Moderator: Marcelo De Oliveira, Consultancy Manager, NORDIKA, Brazil
      Serialization Impacts Beyond the Packaging Lines
    • Lars Olsen, Global Technology Partner, NNE Pharmaplan, Denmark
      Overview on serialization and T&T Worldwide – regulations and practical experience
  • Data Integrity - Part III Tuesday, 14 October 08:15 - 09:30
  • Data integrity surrounding computer system supported business processes has been at the forefront of recent news e.g., Ranbaxy and Obama Care, and the awareness of these issues has changed the approach used by regulators in conducting inspections in recent years. As data integrity has become the focus of regulatory inspections, the industry has to recognize and ensure controls for data integrity are implemented and appropriately managed throughout the data's entire lifecycle. Problems with data integrity manifest themselves differently in each phase of the lifecycle. Therefore improvements must be managed differently during each phase. Industry must change because -
    o Industry has gone to increased use of computer systems for efficiency gains.
    o Software with advanced capabilities for capture and review of data history.
    o Regulatory agencies have learned to review data leading to changes in how they conduct inspections
    Industry needs to learn how to establish controls to identify data integrity issues in process. While focusing on the identification of issues is important it is just as important to focus on identification of pragmatic approaches and mitigation strategies.

    • Leader: Michael Rutherford, Consultant - Laboratory and Quality Systems, Eli Lilly & Co, USA
    • Leader: Lorrie Vuolo-Schuessler, Manager, Computer Systems Quality Assurance, GlaxoSmithKline, USA
    • Moderator: James Eichelman, President & Principal Consultant , James Eichelman and Associates, LLC, USA
      Lab Workshop - Data Integrity Risk, Detection and Controls
    • Moderator: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
      Clinical Workshop - Data Integrity risk, detection and controls
    • Moderator: Eric Staib, Executive Director of Quality Assurance, PRA Health Sciences, USA
      Clinical Workshop - Data Integrity risk, detection and controls
    • Moderator: Christopher White, Associate Director, E-Quality Systems, Alexion Pharmaceuticals, USA
      Lab Workshop - Data Integrity Risk, Detection and Controls
    • Mark Newton, Associate Senior Consultant QA, Eli Lilly & Co, USA
      Workshop Introduction- Data Integrity Risk, Detection and Controls
  • Current Status and Trends on Serialization and Track&Trace - Part II Tuesday, 14 October 10:15 - 11:30
  • - Reasons and motivation that caused the increase of the importance of serialization and T&T Worldwide
    - Current status and tendencies on serialization and T&T in the World - existent and future regulations and their differences and similarities. How fast the suppliers and the industry are advancing by their side and preparing themselves (short, mid and long term expectations)
    - Technologies and technical aspects for serialization and T&T - currently available and trends
    - Case studies and practical examples on serialization and T&T implementation, operation and maintenance
    Interfaces of serialization and T&T with other management and technical areas

  • Data Integrity - Part IV Tuesday, 14 October 10:15 - 11:30
  • Data integrity surrounding computer system supported business processes has been at the forefront of recent news e.g., Ranbaxy and Obama Care, and the awareness of these issues has changed the approach used by regulators in conducting inspections in recent years. As data integrity has become the focus of regulatory inspections, the industry has to recognize and ensure controls for data integrity are implemented and appropriately managed throughout the data's entire lifecycle. Problems with data integrity manifest themselves differently in each phase of the lifecycle. Therefore improvements must be managed differently during each phase. Industry must change because -
    o Industry has gone to increased use of computer systems for efficiency gains.
    o Software with advanced capabilities for capture and review of data history.
    o Regulatory agencies have learned to review data leading to changes in how they conduct inspections
    Industry needs to learn how to establish controls to identify data integrity issues in process. While focusing on the identification of issues is important it is just as important to focus on identification of pragmatic approaches and mitigation strategies.

  • Current Status and Trends on Serialization and Track&Trace Part III Tuesday, 14 October 13:00 - 14:30
  • This presentation will provide an analysis of the current understanding of IT infrastructure qualification with a major focus on data integrity. Furthermore, guidance will be provided to ensure regulatory compliance of IT infrastructure systems regarding current GxP regulations. This is imperative to ensure successful and compliant flow of information through the automated business processes, as well as data integrity, confidentiality and availability within the layered IT infrastructure systems.
    2.) - Terms, paradigms and principles
    - Standardization of processes and technologies
    - Other industry standards used to implement an IT infrastructure and to control the data held within them
    - Flow of information - a business or an IT topic?
    - Layer Model • How to differentiate business applications from IT infrastructure systems
    - What are the requirements for data integrity within the IT infrastructure
    - IT infrastructure landscape (with a focus on data integrity)
    - Which IT services/processes are necessary and how do they need to be implemented
    - Building-block principle and how to reduce redundancy within the systems landscape
    - What is the role of Configuration Management
    - Definition of SLAs with third party suppliers
    - Outsourcing vs. Cloud computing • quo vadis

  • How well do you Maintain Control of your Computer Systems? Tuesday, 14 October 15:30 - 17:00
  • Many validated computer systems are not well maintained and become progressively more non-compliant as a result of fixes and changes. This session will help delegates to identify the activities necessary to remediate these compliance issues. The session will apply a similar approach to their change management systems resulting in the identification of opportunities for improvement.
    This program will consist of two interactive bench-marking activities for:
    o Maintaining Control of Validated Computer Systems
    o Change Management for Computer Systems
    Delegates will be able to score their own systems either interactively or using a score sheet to determine activities they do well and others that require improvement. Data will be presented from other bench-marking activities for comparison. The bench-marking activities will be supplemented by short presentations highlighting good practices for those areas traditionally scoring low in such bench-marking exercises.

    • Leader: David Selby, PhD, Managing Director, Selby Hope International Ltd, United Kingdom
      How well do you maintain the Validated State?
    • Arthur Perez, PhD, Information Governance-Management, Retired, Novartis Pharmaceuticals, USA
      Project Handover and Post-Mortem
  • Hot Technologies: Mobile Applications and Strategies for Managing Software Risks in the Cloud Wednesday, 15 October 08:00 - 09:15
  • Two technologies that healthcare companies are just beginning to leverage are mobile devices and the cloud. Mobile apps provide a unique opportunity to reach patients directly, whether as a part of treatment or as a marketing tool (or even as a combination of the two). Cloud technology provides the possibility to securely manage information externally, with the incentives of lower cost and potentially easier broad access to that information for people who need it. This session will look at the challenges and opportunities that these technologies present.

    • Leader: Arthur Perez, PhD, Information Governance-Management, Retired, Novartis Pharmaceuticals, USA
    • Kathleen Gniecko, IT Quality Management Services Head, F. Hoffmann - La Roche AG, Switzerland
      Strategies for Managing Software Risks in the Cloud
    • Sion Wyn, Director, Conformity Ltd., United Kingdom
      Mobile Applications
  • Strategies for Enhanced Quality and Security Wednesday, 15 October 11:00 - 13:00
  • Paperless Lab to support Quality by Design (QbD) initiatives: QbD will be the norm within 10 years and manufacturing efficiency will be significantly improved . Adoption of an integrated Product Quality Lifecycle Process facilitates innovation, continual improvement and strengthens the link between pharmaceutical development and manufacturing activities. The power of a Paperless Laboratory is the ability to enable organizations to implement self-documenting processes that produces both non and GxP-compliant documentation which eliminates unnecessary tasks from the workflow, to result in a significant cost of non-compliance to support corporate Cost of Goods Sold (COGS) optimization. This presentation will highlight how QbD and Paperless Lab processes enables organizations to create start-to-finish knowledge management repository to adopt cross functional collaboration between management, scientists and engineers responsible for products in development and manufacturing, processes, equipment and facilities.

    Planning and Implementation of GxP relevant IT infrastructures - A data oriented perspective: Since the 2011 publication of the EU GMP Annex 11, the qualification of the IT infrastructure of pharmaceutical companies is officially required. It is formulated as a general requirement without details on the implementation of such systems. Firms have to interpret this rule, which may lead to confusion. Because IT infrastructure systems retain all the business data it is justified to ask how these systems are implemented and how the system owners control the data integrity within the operational phase of these computerized systems. This presentation will provide an analysis of the current understanding of IT infrastructure qualification with a major focus on data integrity. Furthermore, guidance will be provided to ensure regulatory compliance of IT infrastructure systems regarding current GxP regulations. This is imperative to ensure successful and compliant flow of information through the automated business processes, as well as data integrity, confidentiality and availability within the layered IT infrastructure systems.

    Securing Information as part of the Global Supply Chain: Every organization in the US pharmaceutical has some component of a global operation that requires information transfer. Securing this information, particularly in light of escalating operations in Asia requires a clear plan for securing high value information. This discussion will review the considerations for addressing the cybersupply chain, discussing technology, risk management and business solutions to effectively manage a global information infrastructure.

Executive Series

Track Director:

Gordon Leichter, Ph.D., Regional Sales Manager, Belimed, Inc.

Planning well for the future of your organization requires insight well beyond the day-to-day challenges. Benefit from lessons learned by other executives offering strategies and innovations to help you envision your own facilities using next-generation design, new approaches to achieve operational excellence and turning out new and profitable product lines.

Click on the SESSION TITLE below to view additional information

  • EXECUTIVE SERIES: FOYA CATEGORY WINNERS - PART I Monday, 13 October 12:30 - 14:30
  • Get an in-depth look at the latest, state-of-the-art developments being implemented, the winning projects, and see how excellence was delivered via innovative thinking. Featured presentations include the 2014 Facility of the Year Awards Program Category Winners.

  • EXECUTIVE SERIES: FOYA CATEGORY WINNERS - PART II Monday, 13 October 15:30 - 17:30
  • Get an in-depth look at the latest, state-of-the-art developments being implemented, the winning projects, and see how excellence was delivered via innovative thinking. Featured presentations include the 2014 Facility of the Year Awards Program Category Winners.

  • EXECUTIVE SERIES: Solutions for Manufacturing of the Future - Part I Tuesday, 14 October 08:15 - 09:30
  • Everybody involved in pharmaceutical and biopharmaceutical manufacturing is increasingly challenged to be faster, more efficient, and more flexible in producing and delivering products globally. This session will highlight some of the most challenging and also most promising areas for pharmaceutical manufacturing in the future.
    Production Efficiency
    - Single Use Solutions
    - Continuous Processing
    - Flexible Facilities
    Implementation Efficiency
    - Standard Solutions
    - Modularization
    Globalization

  • EXECUTIVE SERIES: Solutions for Manufacturing of the Future - Part II Tuesday, 14 October 10:15 - 11:30
  • Everybody involved in pharmaceutical and biopharmaceutical manufacturing is increasingly challenged to be faster, more efficient, and more flexible in producing and delivering products globally. This session will highlight some of the most challenging and also most promising areas for pharmaceutical manufacturing in the future.
    Production Efficiency
    - Single Use Solutions
    - Continuous Processing
    - Flexible Facilities
    Implementation Efficiency
    - Standard Solutions
    - Modularization
    Globalization

  • EXECUTIVE SERIES:
    Baxter Healthcare Corporation- Integrated Plasma Protein Manufacturing Facility: Mid-Term Report Tuesday, 14 October 13:00 - 14:30
  • Very large organizations like Baxter are challenged to be lean and to operate as efficiently as possible with respect to staff headcount and spending. When giant new projects are initiated, large groups of internal “volunteer armies” as Baxter calls them, are asked to add the planning of a new campus to their already heavy loads. This causes enormous stress in an organization. As design completion happens and the focus transitions to construction, timely decision making becomes even more essential. As a follow-up to the 2013 executive series of the Baxter Covington project, our session will detail the ways in which Baxter organized both internally and externally to be successful using existing staff, new hires, external consultants and industry best practices. The opportunities for participants in the session include developing a keen awareness of these challenges on management and organization as well as lessons learned during the process that may assist them in their next large endeavor.

    • Leader: Jerald Polly, Principal, Flad Architects, USA
    • Zenon Farion, Director Capital Project Management, Fluor Life Sciences, USA
    • Bailey Forrest, Sr. Project Manager, Fluor, USA
      Construction Phase Challenges & Solutions, Part 1
    • Robert Goworek, Vice President & General Manager, Turner Pharmaceutical, USA
      Construction Phase Challenges & Solutions, Part 2
    • Peter Neuper, Director, PMO, Baxter Healthcare Corporation, USA
      Key Baxter Project Drivers
    • Clay Seese, Mechanical Engineer, CRB, USA
      Process System Procurement & Coordination
  • EXECUTIVE SERIES:
    FIT Talk Series: Lessons Learned from 4 Decades of Biomanufacturing Tuesday, 14 October 15:30 - 17:00
  • Following up the successful 2013 AM FIT Talk session, the session will focus on the lessons of the past and how biomanufacturing is being shaped for the next decade. Using the FIT Talk format, Industry Experts will share their "life lessons" in biomanufacturing and framework how these lessons are moving biomanufacturing into the next decade.
    * Global SMEs in biomanufacturing design and operations will share their experiences, both successes and failures, that have shaped the growth of the biotech industry today
    * Personal experience is the baseline of learning. The sharing of these experiences will provide a unique learning opportunity for all who attend the session
    * The diversity of personal and corporate experiences will provide how new ideas have been developed that have led to many new innovations in facility design and manufacturing operations. This evolution continues today across the Industry.
    * Best practices are shaped by what we learn from our failures. This will be a first-hand opportunity to hear how it is done by the experts.

  • EXECUTIVE SERIES: Operational Excellence - Part I Wednesday, 15 October 08:00 - 09:15

  • Is there a disconnect between you OPEX program and your Pharmaceutical Quality System?


    Are your key resources chasing recurring deviations or repeat quality failures?


    OPEX is not just about productivity, cost or yield. It is about achieving excellence in all aspects of your operations including improving quality of the product.

    This session will present the findings from two research programs on the benefits of embedding Excellence into your Quality Management Systems to enhance quality culture and measure the benefits.

    • Leader: Nuala Calnan, PhD, Research Fellow, Dublin Institute of Technology, Ireland
      Embedding Quality and Excellence and Measuring the Benefits- an Irish Industry Research Study and LQI Quality Metric Tool Development
    • Leader: Thomas Friedli, PhD, Director of Institute of Technology Management, University of St. Gallen (Switzerland), Switzerland
      University of St.Gallen – OPEX Benchmarking Model for the Pharmaceutical Industry
    • Ann Gillan, Strategic Quality Projects Leader, Roche Irl Ltd, Ireland
      OPEX & PQS Implementation- Roche Ireland Limited
    • Conor Moloney, QA Specialist, Roche Ireland Ltd, Ireland
      OPEX & PQS Implementation-Roche Ireland Limited
  • EXECUTIVE SERIES: Operational Excellence - Part II Wednesday, 15 October 11:00 - 13:00

  • Is there a disconnect between you OPEX program and your Pharmaceutical Quality System?


    Are your key resources chasing recurring deviations or repeat quality failures?


    OPEX is not just about productivity, cost or yield. It is about achieving excellence in all aspects of your operations including improving quality of the product.

    This session will present the findings from two research programs on the benefits of embedding Excellence into your Quality Management Systems to enhance quality culture and measure the benefits.


Manufacturing Facilities and Design

Track Director:

Jim Gazvoda, Principal, Flad Architects

Two comprehensive streams of content related to manufacturing facilities will be offered for participants committed to innovation and sustainability.

Click on the SESSION TITLE below to view additional information

  • Operational Excellence: Facility Master Planning, Manufacturing Capacity and Cost Modeling Sunday, 12 October 13:00 - 15:00
  • A key aspect of Operational Excellence is performing manufacturing in the most cost effective manner possible. This includes the minimum labor, equipment and supporting services, use of WIP, etc. to meet current business needs while allowing for reliability and future growth. At many sites, creative and resourceful staff have a plethora of ideas for improvement but lack a method of comparing these alternatives and selling the most attractive improvements to management. Justifying changes to an operating, validated process in the life sciences industry can be especially challenging. Dynamic process models are frequently used to understand constraints which exist in a manufacturing facility. These constraints may reside in equipment, CIP, utilities, labor or operating schedules. Simulations quantify the impact of these constraints and are used to study alternative methods of removing them. To address the problem of cost justifying improvement projects, we propose adding cost information, by batch and by operating step, to the traditional process model. Costs are tracked versus time and cost profiles can be compared before and after a proposed improvement. This approach allows a single tool to provide both the throughput and the cost advantage gained by the change. This information will be used to justify the project or recommend its postponement or elimination. In this presentation two case studies will be used: biotech (mammalian cell culture) and pharmaceutical (OSD), to demonstrate the value of using a combined process and cost model. Best practices in model development will be described. Examples of improvements will be compared on the basis of throughput and costs, along with the cost of implementation. These results feed directly into a business case for project approval and the realization of the benefits.

  • Case Study - New High Purity Water System Technologies Deliver Reliability & Sustainability for GSK Sunday, 12 October 13:00 - 15:00
  • Problem or Opportunity Statement:
    GSK's Building UM38 (B38) Biopharmaceutical CTM Pilot Plant's High Purity Water Project is almost complete. The project consisted of the replacement of existing, obsolete Purified Water (PW) and Water-for-Injection (WFI) generation systems with new systems that delivers environmental sustainability benefits, improves reliability for manufacturing operations, and reduces the pilot plant's water systems operating expenses. The newly installed systems have full redundancy to ensure the reliable supply of PW and WFI to the clinical trial material manufacturing operations.

    Phase 1 of the project was the replacement of Facility's PW system, which consisted of installing two new redundant RO/CDI PW generation trains. This phase required construction of a new two story mechanical room for the new equipment, which was installed and validated prior to connecting it to the Building's existing validated PW distribution system. The new PW system represents the latest water purification technology for energy and water efficiency in the production of USP grade water and will help the Upper Merion site to achieve its water reduction goals of >20% by 2015.

    The new RO/CDI PW generation trains include technology to significantly reduce water and energy consumption compared to conventional generation systems. This translates into a more environmentally responsible, energy-efficient water purification process that will yield a significant reduction in operating expense. Initial estimates of the benefits are:

    • Water consumption reduction of approximately 11,000 gallons per day (4M gallons per year) with cost savings of ~$30K per year including sewer costs.

    • Electrical energy savings for pumping operations was reduced by 88% and will save ~$23k per year.

    • Annual carbon emissions reduction of 206 TONNES CO2.

    • Further operational savings of up to $87K per year will be realized by having the new system also supply high purity water to the non-GMP development pilot plant, thus eliminating the need of operating a costly resin bed train service contract presently utilized.


    Phase 2 of the project consisted of removing the old RO/CDI PW generation equipment from the B38 basement mechanical room and installing two new redundant Vapor Compression (VC) WFI stills that are replacing a single 25 year old multi-effect WFI still. The new VC stills will also produce significant energy savings while ensuring needed reliability for the B38 CTM pilot plant, which continues to experience an increase in its utilization and output to meet the BioPharmaceutical portfolio demands. GMP release of these systems is targeted for September 2014.

    • Leader: Brian Termine, PE, Engineering Maintenance Manager, GlaxoSmithKline, USA
      Results (benefits, savings, lessons learned)
    • Brian Lipko, PE, Senior Manager, Hargrove Life Sciences, USA
      High Purity Water System Technologies
    • Steven Walter, CPIP, Process Technology Leader, Hargrove Life Sciences, USA
      Introduction (background, objectives, challenges)
  • ADM Concepts as a Model for Next Generation Biomanufacturing Monday, 13 October 09:30 - 10:15
  • The drivers for creating Advanced Development and Manufacturing (ADM) centers for the production of vaccines and biologics are well-aligned in some areas of the public and private sectors. The ADM business model is designed to provide a flexible, adaptive and scalable biomanufacturing capacity with the ability to transition quickly and cost effectively between products. These facilities leverage modern manufacturing technologies that have the potential to produce biologics more quickly and in a more affordable way. The use of these technologies are intended to enable multiproduct and multiphase manufacturing of a variety of products quickly enough to respond provide surge capacity and respond to sudden shifts in product demand.
    This presentation will explore strategies to retrofit existing facilities or build new ones to incorporate flexible, nimble and innovative manufacturing platforms that can be used for multiproduct biologics manufacturing.
    1. Describe ADM Approach. a. What is ADM?
    b. Business drivers for ADM implementation (interactive audience polling)
    c. ADM enabling technologies.
    d. Challenges to implementation.
    2. Impact on design of new facilities and equipment for biologics manufacturing.
    a. Drug substance manufacturing facilities
    b. Drug product manufacturing facilities
    c. Quality/Regulatory considerations
    3. Concepts for implementing ADM in Legacy Biomanufacturing Facilities
    a. Hybrid approaches
    b. Opportunities to reduce cleanroom classification
    c. Opportunities to improve flexibility and agility

    • David Marks, PE, President, DME, USA
      ADM Concepts as a Model for Next Generation Biomanufacturing
  • Demand Flow - A Unique, Proven & Holistic Energy & Operational Cost Savings Application for Water-Cooled, Central Chilled Water Systems Monday, 13 October 09:30 - 11:00
  • Per ARI standards, chilled water systems are often operated inefficiently 95% of the time. Per ASHRAE, chilled water systems that operate at 0.8 kw/ton or greater (on an annual average for chiller, pump and cooling tower fan energy combined) are systems that are in need of improvement. The typical Demand Flow® plant operates in the 0.5 to 0.7 kw/ton range on an annual average for the same combined equipment. Also, the general belief is that plant efficiency needs to be sacrificed to maintain comfort. Utilizing a holistic approach to optimizing the entire chilled water system, Demand Flow® not only provides world class efficiencies but also provides improved comfort/process cooling. Discuss how the use of variable-speed-pumping/variable-pressure-curve technology can optimize a central chilled water system to reduce the overall energy consumption on average by 20-50%. This new technology not only provides energy savings but allows for a simpler method of control that is more intuitive to the plant operators. The presentation will include specifics related to common industry characteristics and their shortcomings. We'll discuss the effects of this new technology on the Mollier curve; specifically its effect on chiller "Lift" and "Refrigeration Effect" to produce energy savings and increase system deliverable tonnage, respectively. Highlights will include the technology's ability to enable seamless switchover between mechanical and free cooling to maximize water-side economizer usage. Case studies will be discussed to show examples of expected results.

  • Oral Solid Dosage Manufacturing Facilities Monday, 13 October 09:30 - 11:00
  • This session will provide attendees with an overview and update of the current industry trends, technologies and key issues relating to the planning, designing, engineering and qualification of today’s modern OSD manufacturing facilities. Will be based on trends and issues relating to renovations of aging facilities, as well as construction of new facilities, with a combined technical and business justification slant. Among the key concepts covered: What are the keys to a successful OSD facility design, and what is the appropriate scope of an OSD project? We will discuss the importance and impacts of pre-planning, and the relationship of those activities to meeting regulatory requirements. We will also explore how effective pre-planning and programming can impact the successful delivery of on OSD capital project. Additionally, we will review the financial impacts of a project, the current equipment technologies available and how containment must be addressed, regardless of product potency to minimize the big issue of cross contamination. Appropriate case studies from major pharmaceutical companies who have recently completed OSD projects will provide real-world examples.

    • Leader: Dave DiProspero, Associate/Director of Pharmaceutical Process Technology, CRB, USA
      ISPE OSD BASELINE GUIDE VOLUME 3 - An Update and Overview
    • C. Alexander Heisterkamp, Project Management, Pfizer, USA
      Planning the OSD facility
    • Robert Matje, CPIP, Principal, RemTech, LLC, USA
      OSD Facility Layout Design Considerations
    • Stephen Sirabian, MBA, Exec. VP Equipment/Eng, Glatt Air Techniques Inc, USA
      Latest OSD Technologies with an emphasis on Product & Personnel Protection and EHS issues
    • Paul Whitby, Director Engineering, Pfizer, Inc, USA
  • Design Assessment Model for Pharmaceutical Drug Manufacturing Facilities Monday, 13 October 10:15 - 11:00
  • Many manufacturing facilities today are designed to satisfy multiple regulatory requirements. This model will discuss a framework for assessing the design in terms of compliance, regulatory and operational considerations. This presentation will review a proven model used in multiple small molecule and large molecule facility design assessments in the US and Asia. The model will cover six major components of the model: Business Strategy, Risk Based Design, Plant Programming, Process Synergy, Supply Chain and Information Systems. Gain a clear methodology for evaluating design risk from a compliance, regulatory and compliance perspective.

    • Bikash Chatterjee, President and CSO, Pharmatech Associates, USA
      A Design Assessment Model for Pharmaceutical Drug Manufacturing Facilities
  • Reliability Centered Design Principles Reduce the Life-Cycle Cost of Assets and Improve Speed to Market - Part I Monday, 13 October 12:30 - 14:30
  • Understanding how the LCC (Life Cycle Cost) of a project is affected by early decisions and perspectives can be quantified by understanding the following facts:
    o 85% of an Asset's Life Cycle Cost is determined at the design phase.
    o Less than 10% of an Asset's Life Cycle Cost is spent prior to start-up.
    o 40% of repeat failures can be related back to the design of the asset.
    o Proactive design translates into improved speed to market.
    Maintenance & Reliability need to be a stakeholder, at the design phase of capital projects, to minimize the LCC (Life Cycle Cost) and optimize the Reliability, Uptime and OEE (Overall Equipment Effectiveness). The Value / Benefits of including Maintenance & Reliability as a Stakeholder at the beginning of each Capital Project goes beyond the expected improvements in safety, quality, reliability, cost, production, reduced investigation time and expense. Reliability Centered Design, a proactive thought process & methodology, can affect Speed To Market for products, equipment and facilities.

    • Leader: Marie Getsug, PMP, CMRP, CPIP, Senior Consultant, Maintenance & Reliability Services, CAI, USA
      Part I - Reliability Centered Design Principles reduce the Life Cycle Cost (LCC) of Assets and Improve Speed To Market
    • John Ganaway, CMRP, Reliability Engineer, Genentech Inc, USA
  • Environmental Control & Sustainability - Part I Monday, 13 October 12:30 - 14:30
  • Energy use for environmental control often represents 50-70% of the energy consumed in pharmaceutical facilities. This energy is a key target for both cost reduction and carbon reduction for environmentally conscious companies. Air change rates are a critical issue in this area, with recent studies and implementation programs yielding as much as 50% reduction in this area. This session is focused on helping Engineering, Quality, Operations and Validation groups in both existing and new facilities to get hands-on experience with cleanroom optimization. Participants will walk away with a practical method to apply and examples. Participants also get the opportunity to interact and benchmarking with their peers in this critical and sensitive (from a regulatory perspective) area. Learn the do's and don'ts of CFD - becoming an increasingly commonly used tool to develop and optimize cleanroom designs. There are a significant number of regulatory observations on poor airflow visualization studies - learn best practices.

    • Leader: Gary Knight, PhD, Project Director, Commissioning Agents, Inc., USA
      Environmental Control and Sustainability
    • Nicholas Haycocks, Senior Specialist QA, Amgen Inc., USA
      Welcome and Introductions background - regulatory requirements
    • Dan Milholland, Managing Partner, Milholland & Associates, USA
      A New Aid to Supplement Airflow Visualization
    • Goncalo Pedro, CFD Consultant, RWDI, Canada
      CFD airflow modeling and it's uses to support airchange reduction
    • Ulla Thomsen, SME HVAC, Novo Nordisk A/S, Denmark
      Airflow vizualization - current best practices
  • Reliability Centered Design Principles Reduce the Life-Cycle Cost of Assets and Improve Speed to Market Education - Part II Monday, 13 October 15:30 - 17:30
  • Understanding how the LCC (Life Cycle Cost) of a project is affected by early decisions and perspectives can be quantified by understanding the following facts:
    o 85% of an Asset's Life Cycle Cost is determined at the design phase.
    o Less than 10% of an Asset's Life Cycle Cost is spent prior to start-up.
    o 40% of repeat failures can be related back to the design of the asset.
    o Proactive design translates into improved speed to market.
    Maintenance & Reliability need to be a stakeholder, at the design phase of capital projects, to minimize the LCC (Life Cycle Cost) and optimize the Reliability, Uptime and OEE (Overall Equipment Effectiveness). The Value / Benefits of including Maintenance & Reliability as a Stakeholder at the beginning of each Capital Project goes beyond the expected improvements in safety, quality, reliability, cost, production, reduced investigation time and expense. Reliability Centered Design, a proactive thought process & methodology, can affect Speed To Market for products, equipment and facilities.

    • Leader: Marie Getsug, PMP, CMRP, CPIP, Senior Consultant, Maintenance & Reliability Services, CAI, USA
      Part II - Reliability Centered Design Principles reduce the Life Cycle Cost (LCC) of Assets and Improve Speed To Market
    • John Ganaway, CMRP, Reliability Engineer, Genentech Inc, USA
  • Environmental Control & Sustainability - Part II Monday, 13 October 15:30 - 17:30
  • Energy use for environmental control often represents 50-70% of the energy consumed in pharmaceutical facilities. This energy is a key target for both cost reduction and carbon reduction for environmentally conscious companies. Air change rates are a critical issue in this area, with recent studies and implementation programs yielding as much as 50% reduction in this area. This session is focused on helping Engineering, Quality, Operations and Validation groups in both existing and new facilities to get hands-on experience with cleanroom optimization. Participants will walk away with a practical method to apply and examples. Participants also get the opportunity to interact and benchmarking with their peers in this critical and sensitive (from a regulatory perspective) area. Learn the do's and don'ts of CFD - becoming an increasingly commonly used tool to develop and optimize cleanroom designs. There are a significant number of regulatory observations on poor airflow visualization studies - learn best practices.

    • Leader: Gary Knight, PhD, Project Director, Commissioning Agents, Inc., USA
    • James Ahearn, Engineer, Roche/Genentech, USA
      Workshop with Case Studies
    • Norman Goldschmidt, Senior Principal, Vice President, Genesis Engineers Inc, USA
      Sustainability: Airchange Rate Optimization
    • Nicholas Haycocks, Senior Specialist QA, Amgen Inc., USA
    • Nigel Lenegan, Managing Director, Energy & Carbon Reduction Solutions Ltd., United Kingdom
  • Sustainability: Facility Engineering and the True Cost of Water Tuesday, 14 October 08:15 - 09:30
  • Sustainable Facility Engineering and Operational Excellence in the Pharmaceutical Industry:

    In the last decade the pharmaceutical industry is moving toward to consider the life cycle of a facility right from the beginning to embed the best concept not only for the design also for the future operation of a pharmaceutical production. Therefore for an engineering and construction company the challenge lies in the consideration of all disciplines and technological innovations involved in the design, construction, commissioning and operation of a sustainable pharmaceutical facility. Most engineering companies, machine suppliers and automation specialists are focused on the optimization of the process equipment and in the operation of the facility while the pharmaceutical manufacturer most interests is in the optimization of the overall production process which is linked to the operation excellence. Today there is a big discussion how to balance best CAPEX and OPEX by investments in new and existing production facilities and what is the best approach to meet the market needs. With modern engineering and simulation tools different production scenarios can be derived, production parameters for commis-sioning evaluated and forecasts for new products and production environment determined. Some of the basic techniques like Lean and Six Sigma will be covered in the session and also how to incorporate the methodologies to meet the objectives of operational excellence and sustainable principles. Beside the need to meet the highest product quality (GMP), maximum equipment throughput, more productive operations and maintenance there will be a special focus how to streamline lower utility costs, less waste and best EHS compliance. Finally reliable benchmarks and metrics for the different pharmaceutical production facilities will be dis-cussed for quick investment decisions for new facilities or retrofits. Benchmarks related to the operation are necessary to improve existing processes and of course to have a clear view how to consider life cycle cost for the on-going manufacturing.

    True Cost Of Water & Monetizing of Blue Risk:

    This presentation explains the True Cost of Water which takes into account direct water costs - both capital and operating expenditures, i.e. CAPEX & OPEX - , indirect water costs - such as legal and administrative costs related to water - and the financial implications of water risks during the lifetime of a plant. Water-related risks are already impacting industries and municipalities. And external factors, such as climate change and population urbanisation will exacerbate those risks. Whereas water footprint indicators give us insight into the vulnerability and resilience of a specific activity to water challenges, decision-makers are now looking for an even more pragmatic and straightforward metric to take water investment decisions that ensure long-term profitability. Cutting-edge solutions to mitigate blue risks already exist to help cities and industries face risks of water scarcity. This presentation will explain how to map out direct and indirect costs and monetizing water related risks.

  • Steam System Optimization & Efficiency Tuesday, 14 October 10:15 - 11:30
  • Regular surveys minimize the number of deficient traps in a system, optimizing efficiency, decreasing process downtime and removing potential safety concerns. Energy savings from repairing failed traps typically result in a simple payback of less than one year. Steam systems work day in and day out behind the scenes in many of our facilities, providing energy to our processes and heat to our buildings. Steam is an efficient way to distribute large amounts of heat energy to a wide variety of end users, while utilizing existing infrastructure. For the most part, steam systems require relatively little in the way of maintenance to maintain efficiency. Annual boiler inspections, diligent water testing and routine heat exchanger cleaning are all regularly carried out in most facilities. However, failure to regularly test and repair all steam traps in your steam system can lead to extreme energy losses, process control problems and operational issues such as water hammer, leaks and broken pipes.

  • Process/CIP/SIP Integration for Operational Sustainability Tuesday, 14 October 13:00 - 14:30
  • This presentation will address how the thorough integration of the Process/CIP/SIP systems into the facility plan during the Basic Design Phase can ensure the long term sustainability and operational excellence. The presentation will cover the marriage of the building plan with the process equipment layout, and its impact on construction, installation and operational costs. Proper planning can reduce the day-to-day operating costs for process, CIP and SIP operations over the life of the facility. The proper selection of a CIP Unit for the process and its location within the building, as well as the relationship of the CIP and SIP distribution systems will be discussed. The group discussion will explore how the Basic Design Phase decisions such as control system architecture, process flexibility, and User Requirement definition can make or break the facilities ability to achieve operational excellence, and impacts sustainability. In addition, the presentation will identify key challenges to overcome to achieve extended CIP and SIP hold times, and how this contributes to elevating operational efficiencies.

  • Innovative Facility Delivery Methods - Gain Acute Understanding of Op Excellence & Best Practices Leveraged from Related Manufacturing Industries Tuesday, 14 October 15:30 - 17:00
  • How do other manufacturing industries similar to the Pharmaceutical industry meet changing market demands? A comparative study on Innovative and Cost Effective Manufacturing Facilities Strategies and Solutions from five related industries will be discussed. Pharmaceutical firms will gain an acute understanding of the benefits of leveraging process improvement tools and techniques from the manufacturing world in order to more effectively manage facility design and construction and product manufacturing, while significantly reducing costs and improving flexibility in their facilities worldwide.

  • Biopharmaceutical Process Carbon Modeling & Optimization Wednesday, 15 October 08:00 - 09:15
  • In an effort to increase environmental stewardship and reduce utility costs, many biopharma companies are setting corporate sustainability mandates in the form of carbon footprint reductions. Additionally, carbon is being used as a decision-making tool by many corporations when looking to implement capital projects related to facilities or site improvements. Using carbon emissions modeling software offers insight into the carbon footprint of all materials used in a biopharmaceutical manufacturing process. In order to capture all contributors to the manufacturing process, every unit operation must be documented individually and accounted for in the modeling. All carbon emissions for raw materials and consumables are determined given the material composition, preparation and delivery methods and routes of disposal. Since facilities operations are a major contributor, these calculations are done in detail. CRB's expertise allows us to accurately calculate energy usage, with built-in flexibility for changes. Accounting for each contribution is done on a per batch basis. This allows the client to break down carbon emissions per batch, per year and even per gram of product output (based on grams per batch). This can prove highly useful when comparing different products to one another and understanding carbon intensive portions of a process. Carbon models were generated for 4 products; 2 mammalian, 2 microbial - 1 large scale / 1 small scale for each. Detailed graphs are created to illustrate major contributors to the process in terms of kg of CO2 and also percent. Since the carbon models and "behind the scenes" energy calculations are developed with built-in flexibility, scenario-based modeling can be done relatively easily; what happens if airflow is reduced in a space? What if we switch to disposables? What if products were stable at ambient temperatures and the cold chain eliminated? What is the impact of alternate delivery methods? In this session we will look to walk through the steps of carbon modeling these biopharmaceutical processes, the fundamentals of the carbon emissions modeling software and results of the baseline process scenarios completed, along with summary findings.

  • Tools for Achieving and Mantaining Operational Excellence Wednesday, 15 October 11:00 - 13:00
  • Facing Your Challenges without a Black Belt:/strong>

    Operational Excellence is about more than special projects led by highly trained Black Belts. Professionals working outside of formal OpEx efforts also have an opportunity to work more effectively using some of the tools associated with OpEx / Six Sigma. This presentation will demonstrate some basic tools that all professionals can apply to solve problems more effectively.

    Energy Efficiency in Labs:

    Lab facilities typically have energy costs that are 3 to 8 times that of an office building. 2/3 of energy use in a laboratory is associated with ventilation. Reductions in airflow will result in significant energy savings. Recent changes in industry codes and standards allow for lower airflows in fume hoods and reduced ventilation air changes in lab spaces. A significant opportunity exists to reduce overall energy usage.

Young Professionals

Track Directors:

Jennifer Lauria Clark, SE Mgr Technical Services, Commissioning Agents, Inc
Brody Stara, Validation Engineer, Commissioning Agents, Inc

This all-inclusive track is developed for young professionals or existing manufacturing professionals looking to enhance their education with the basics of good quality. The track contains dynamic sessions including round tables, case studies and proactive discussions on the quality aspects of critical utilities, GAMP®, facility design and many more!

Click on the SESSION TITLE below to view additional information

  • Disposables 101 Monday, 13 October 12:30 - 14:30
  • Project and Operating Challenge: Why are GCP Systems different (or not?) Tuesday, 14 October 08:15 - 09:30
  • In the GMP and the GLP world, principles on validation of computerized systems are well known and GAMP is established as an industry guideline for these processes. Over the years, the fundamental principles of the life cycle approach in GAMP have been expanded at a high level to be equally applicable across all GxP regulated industry areas. The proposed session addresses the specific GCP challenges and the following main questions: Why are GCP Systems different (or not)? How can GAMP principles be applied to address GCP System validation challenges?
    - Understand GCP Data & System challenges - Understand the project and operating phase during the conduct of clinical trials
    - Understand the importance of the project phase with regard to the operational phase
    - Describe and understand the GCP Process/Layer model
    - Understand the challenges on the different system layers
    - Analyze the GAMP principles (Project and Operating) with regard to the GCP requirements
    - Understand IT-Infrastructure as a layered system for GCP applications

    • Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
      Project and Operating Challenge: Why are GCP Systems different (or not?)
  • Designing for Operational Excellence Tuesday, 14 October 10:15 - 11:30
  • An inefficient layout and design can increase operational wastes (i.e. non-value added activities), thereby negatively impacting the facility efficiency. Applying Lean Six Sigma techniques can be accomplished during the initial facility design to improve layout efficiency and minimize cost. Striving for Operational Excellence doesn't need to wait until a facility is operational. Op Ex and Lean procedures should be applied at the project concept. An inefficient layout and design can increase operational wastes (i.e. non-value added activities), thereby negatively impacting the facility efficiency. Lean wastes, particularly, excessive motion, transportation, waiting, and excessive inventory can be attributed to facility inefficiencies such as poor adjacencies, inadequately sized staging spaces and equipment. Applying lean six sigma techniques as part of the initial concept design phase can help reduce capital investment and operational expenses. Additionally, applying these techniques provide an opportunity to improve sizing and layout by optimizing travel paths, storage spaces, material handling equipment and processes.
    In this presentation, the concept of incorporating lean six sigma tools and techniques during the design phase will be discussed. In addition, the following case studies will be presented to show the results that can be achieved.
    o Master Planning - Improving operations to meet forecasted demands, while minimizing capital investment and staffing expenditure.
    o Lean Facility Design - Understanding user requirements and operational issues during facility programming to optimize the layout with respect to travel paths and equipment sharing.

  • Competencies: A Strategy to Eliminate 483/Regulatory Observations Tuesday, 14 October 13:00 - 14:30
  • Develop a competency learning and training strategy to inspection-proof your organization while building a quality culture and employee engagement. For the last 5 years, training observations have ranked in the top 10 FD483 inspection observation for the pharmaceutical industry. Regulatory agencies, ISO, the Malcolm Baldrige Quality Award and other award and accreditation organizations have moved from asking if employees are trained, to documenting training, to documenting employee learning, to competencies. The presenters show how their organization is moving from management of training to competencies. A well designed competency program demonstrates each employee's learning and their ability to complete and understand job tasks thus inspection proofing the organization to 483 and other agencies' training observations. It also provides employees with concrete training and job knowledge requirements and expectations which improves employee engagement. This model also guides and supports organizational strategy to build and sustain a quality culture. Examples include competencies expected of employees throughout an organization such as quality, and customer service. Examples of competencies and lessons learned on how to design them will be provided. At the end of the session attendees will practice writing a competency.

  • Critical Utilities 101 Tuesday, 14 October 15:30 - 17:00
  • The session would begin with an overview of critical utilities (water, clean steam, compressed air, and process gasses) and why the utilities are considered critical. The session will then review the critical design and installation requirements for water, clean steam, and process gas systems and how they relate to maintaining the critical quality attributes for the utility systems. The session will end with an overview of quality monitoring and commissioning/qualification requirements for critical utility systems. Throughout the session, CU COP guides will be referenced to illustrate what information is available to Young Professionals from ISPE.

  • Critical Utilities 102 Wednesday, 15 October 08:00 - 09:15
  • The session would begin with an overview of critical utilities (water, clean steam, compressed air, and process gasses) and why the utilities are considered critical. The session will then review the critical design and installation requirements for water, clean steam, and process gas systems and how they relate to maintaining the critical quality attributes for the utility systems. The session will end with an overview of quality monitoring and commissioning/qualification requirements for critical utility systems. Throughout the session, CU COP guides will be referenced to illustrate what information is available to Young Professionals from ISPE.

Project Management

Track Director:

Keith Gibbs, Director of Project Delivery, Innovative Process Solutions

The Project Management Track celebrates its 10th consecutive year of programming. This track will be presented as a celebration of Project Management from the Empire of Rome (Caesars Place) to the modern day marvel that is the Las Vegas Convention Center. Participants will engage in interactive workshops and classroom presentations. At the end of this track, participants will be able to take the “Real World” knowledge home to better their own career in Project Management. And participants won’t have to gamble away the project to do so.

Click on the SESSION TITLE below to view additional information

  • Don't Gamble Your Project Away:
    Real World Lessons of Project Management Top Ten Lessons Learned: A Study in Project Management Monday, 13 October 12:30 - 14:30
  • Three keynote speakers will kickoff our week of “Real World of Project Management” track. All of these speakers will discuss challenges discovered, and solutions found in the execution of their projects. Presentations will focus on the implementation strategies employed in establishing successful project management on projects. Recipients of recent FOYA recognition will share what made their projects successful. Delegates will then be guided through an evaluation of those strategies.

    • Leader: Keith Gibbs, Kage and Sui Generis Ninja Project Management, USA
    • Scot Thomas, Capital Projects Director, Baxter Healthcare Corp, USA
      Top Ten Lessons Learned from the "Craziest" of Projects
    • Aaron Weinstein, Senior Director, Validation Services, IPS, USA
      A Strategy for Remediation Under Consent Decree: Management, Project Controls and Deliverables Related To These Challenging Projects
  • Calculating Odds of Success: A Workshop on Project Management Monday, 13 October 15:30 - 17:30
  • This workshop session will place delegates in a simulated scenario, where a successful outcome is directly related to the way a Project Manager evaluates risk and manages budget with available information, and how that might change over time. Delegates will gain an understanding of the special challenges related to Remediation Projects that are a result of regulatory action Plan and implement a strategy for management of a Remediation Project. Identify the schedule and cost drivers that are specific to Remediation Projects. Navigate the more intense document review and approval cycle associated with increased regulatory scrutiny. We will utilize the principles of Texas Hold’em Poker as applied to Project Management.

  • Starting Your Project with a Plan: Tuesday, 14 October 08:15 - 09:30
  • This presentation will discuss the phased approach to project execution and the feasibility work necessary for a successful project, including the evaluation "gate" and the benchmarks used to compare the feasibility data to stated goals. We will share case study examples of projects with inadequate planning and Capital Requests that were presented to senior management without considering all factors.

    • Leader: John Honey, Head of Engineering, Roche, China
    • Michael Baltes, Head of Project Management, F Hoffmann-La Roche AG, Switzerland
      Project Management Approaches that Support a FOYA Success
    • Dennis Romak, MBA, CPM, VP Strategy & Market Development, Process Plus, USA
      Starting Your Project With A Plan
  • Procurement on Trial: A Workshop on Project Management Tuesday, 14 October 10:15 - 11:30
  • Presentation will focus on the implementation strategies employed in establishing a Project Procurement Plan as part of a successful Project Delivery Plan on a project to streamline the project lifecycle. Project Directors and Procurement Executives will share strategies to avoid risk and be successful.

  • Developing a Risk Assessment Based Culture to Streamline the Project Lifecycle: A Study in Project Management Tuesday, 14 October 13:00 - 14:30
  • Presentations will focus on the implementation strategies employed in establishing a Risk Assessment Based Approach on project to streamline the project lifecycle by focusing resources where they are most needed. Speakers will prsent on "Bringing Pragmatism to Crisis Management." This session is planned for live broadcast via web to allow non-attendees an opportunity to gain value from sessions held at this Annual Meeting. The workshop with presentation and guided exercise will focus on the development of key areas of a Project Risk Assesment.

  • Risk Assessment Tools and their Application: A Workshop on Project Management Tuesday, 14 October 15:30 - 17:00
  • Presentation and guided exercise will focus on the development of key areas of a Project Risk Assesment.

    • Leader: Patricia Melton, PhD, Managing Director, Mime Solutions Ltd., United Kingdom
      Risk Assessment Tools and their Application: A Workshop on Project Management
    • Shannon Chesterfield Yonker, Associate Director, Commercial Manufacturing, Heron Therapeutics, USA
  • Project Capital Efficiency: A Workshop in Project Management Wednesday, 15 October 08:00 - 09:15
  • This presentation highlights some relatively quick and simple ways that capital efficiency can be improved while maintaining essential elements of capital projects: schedule, budget, and quality deliverables.

    • Leader: Dennis Romak, MBA, CPM, VP Strategy & Market Development, Process Plus, USA
      Project Capital Effieciency: A Workshop on Project Management
    • Dennis McCullough, MS, CPP, Vice President, Process Plus, USA
      Project Capital Efficiency
  • The T.R.U.E. Cost of Project Safety Wednesday, 15 October 11:00 - 13:00
  • Presentation will focus on the implementation of a Project Safety Plan, and the benchmark supported rationale for doing so.

Investigational Products

Track Director:

Steve Yoder, General Manager, Fisher Clinical Services

This year’s theme of the Investigational Products (Clinical Trial Materials) track is “Playing the Winning Hand,” which will offer real-world insights and practical applications from industry leaders sharing their knowledge and experience with new technologies and its impact on clinical sites and patient usage. Day One will examine how survey results are shaping the future of clinical supply lines and will show the use of new technology at clinical sites to improve the trial experience. Day Two and Three will offer examples and case studies to provide a deeper understanding of how biotechnology and pharmaceutical companies are utilizing technology to manage and improve the supply chain. Topics will include exploring breakthroughs in e-labeling, management of ambient and cold chain distribution technologies and a closer look on Expanded Access Programs. Participants in this year’s IP track can expect focused presentations and discussions with industry leaders on topics that are critical in managing clinical supply lines to ensure that the participant is holding the cards for a winning hand.

Click on the SESSION TITLE below to view additional information

  • Betting on the Future: The Next Generation of Investigational Products - Part I
    ACPE UAN: 0012-9999-14-242-L04-P Monday, 13 October 12:30 - 14:30
  • Playing the Winning Hand: Application and real world insights as it relates to the clinical sites and patient usage.

  • Betting on the Future: The Next Generation of Investigational Products - Part II
    ACPE UAN: 0012-9999-14-242-L04-P Monday, 13 October 15:30 - 17:30
  • Playing the Winning Hand: Application and real world insights as it relates to the clinical sites and patient usage.

  • Investigational ProductsTechnology and Innovation - Part I
    ACPE UAN: 0012-9999-14-243-L04-P Tuesday, 14 October 08:15 - 09:30
  • Usage of technology to assure compliance, reduce cycle time and waste in the clinical supply process by usage of Elabels. Gain an understanding and awareness of Expanded Access Programs to allow patients access to medicines in the clinical development process and practical examples of how organizations are implementing these programs.

  • Investigational ProductsTechnology and Innovation - Part II
    ACPE UAN: 0012-9999-14-243-L04-P Tuesday, 14 October 10:15 - 11:30
  • Usage of technology to assure compliance, reduce cycle time and waste in the clinical supply process by usage of Elabels. Gain an understanding and awareness of Expanded Access Programs to allow patients access to medicines in the clinical development process and practical examples of how organizations are implementing these programs.

  • Investigational ProductsTechnology and Innovation - Part III
    ACPE UAN: 0012-9999-14-243-L04-P Tuesday, 14 October 13:00 - 14:30
  • Usage of technology to assure compliance, reduce cycle time and waste in the clinical supply process by usage of Elabels. Gain an understanding and awareness of Expanded Access Programs to allow patients access to medicines in the clinical development process and practical examples of how organizations are implementing these programs.

  • Investigational ProductsTechnology and Innovation - Part IV
    ACPE UAN: 0012-9999-14-243-L04-P Tuesday, 14 October 15:30 - 17:00
  • Usage of technology to assure compliance, reduce cycle time and waste in the clinical supply process by usage of Elabels. Gain an understanding and awareness of Expanded Access Programs to allow patients access to medicines in the clinical development process and practical examples of how organizations are implementing these programs.

  • Investigational Products: Hot Topics and Industry Updates - Part I Wednesday, 15 October 08:00 - 09:15
  • Explore the interpretation and impact of the Sunshine Act on the clinical trial arena and updates to ISPE initiatives and future projects.

  • Investigational Products: Hot Topics and Industry Updates - Part II Wednesday, 15 October 11:00 - 13:00
  • Explore the interpretation and impact of the Sunshine Act on the clinical trial arena and updates to ISPE initiatives and future projects.

Changing industry dynamics continue to present new challenges.

Cost pressures, tighter schedules, the need for manufacturing flexibility and shifting regulatory expectations are constant challenges affecting how you conduct business. ISPE’s Annual Meeting will offer you the tools to address those challenges and improve your processes to remain cutting-edge and relevant while delivering high quality medications.

Are you up to date on the latest industry innovations? Science and technology are not the same today as they were just 10 years ago. At the ISPE Annual Meeting you'll hear how you can integrate new manufacturing process, meet regulatory expectations and enhance your quality systems to reshape the way your company does business. Learning these new trends is critical to your day-to-day operations and the success of your organization!

Pinnacle Programme 2015 Global Sponsors