2013 Operational Excellence EU Conference2013 Operational Excellence EU Conference2013 Operational Excellence EU Conference

Share:          

Conference Abstracts

Keynote Speech

The Next Generation of OpEx: Professionalizing - Embedding - Sharpening

  • Comparing with competitors to make informed decisions and determine the right priorities
  • Using data for strategic decisions to set the right degree of complexity
  • Choosing the right projects, the right tools, and the right support structure
  • Illustrating the power of communication to secure engagement and drive results

Speaker:

Prof. Dr. Thomas Friedli, University of St. Gallen

Conference Abstracts

Modularisation – One Way to Operational Excellence

As for most other industries, time to market in combination with flexibility and light financial assets are today key challenges in the pharma industry. Compliance requirements and patient safety are also factors that need to be considered. This puts higher requirements on the life cycle aspect for new facility design and project execution.

Can modularisation and standardisation be the solution for the next generation facility to meet today’s requirement of operational excellence?

This presentation will cover: 

  • Life cycle aspects for new facility design
  • Flexibility
  • Standardisation
  • Modularisation
  • Off-site construction
  • Case study on ”Modular Aseptic Solutions”

Speaker:

Fredrik Eneqvist, Design and Engineering Director, KeyPlants

Focusing on the High-Growth Emerging Markets

The emerging healthcare markets of Brazil, Russia, India China, Mexico and Turkey (BRICMT) are projected to nearly triple in size in the next decade, creating $2B (USD) in economic activity. We will discuss the nature of these opportunities, with particular focus on:

  • What are the local market requirements and how are they evolving?
  • What are local players doing in these markets?  Are they competitors, partners of both?
  • What is the performance difference between those companies that entered these markets early, versus those that waited for the markets to develop?
  • Are there operational best practices to be learned?
  • What other 'emerging markets' exist and how are companies seeking them out?

Delegates will: 

  • Discuss the challenges of growth through emerging markets – regulatory, operational and strategic hurdles
  • Learn from examples on how others have taken advantage of these opportunities

Speaker:

Andrew Gonce, Associate Principal in the Operations Practice, McKinsey & Company

Driving Operational Excellence in Life Science Through MES

You will learn why Driving Operational Excellence in Life Science, through MES and EBR, has caught the attention of Contract Manufacturing Organisations (CMO) and Original and Generic Pharmaceuticals, Biotech, and Medical Device manufacturers. Discover what is working best for key areas, such as: Quality, Compliance, Operations, Automation, and IT Personnel. Previous experience with Manufacturing Execution Systems or Paperless Manufacturing is not required.

This presentation discusses planning for MES from evaluating the benefits of MES, defining goals, positioning MES within the IT infrastructure and aligning stakeholder requirements through development of a coordinated user requirements document. These activities provide the basis for MES software selection and implementation resources. Examples of cost savings available through an MES implementation are included in the presentation.

Facing continuing challenges to reduce manufacturing costs, Life Science companies are looking beyond departmental productivity improvements for cost saving solutions. MES is a technology that can improve the recording process, accuracy, timeliness and usability of data that manufacturing, quality, compliance and other departments rely on to achieve their business objectives. Departmental leadership routinely updates business processes to drive efficiency and address changing compliance requirements within their functional area. MES addresses cost savings opportunities that can only be captured by extending efforts across functional boundaries.

Delegates will gain from this presentation: 

  • Understanding of MES Concepts
  • Establishing an MES Initiative
  • Selling MES Internally
  • How to Setup an MES Programme Management
  • High Level Execution of an MES Project

Speaker:

Marco Lederle, Director Consulting / Partner, i+o Industry Planning + Organization

Capacity Planning and Plant and Supply Chain Network Design (best practice cases)

The pharmaceutical industry operates within a volatile world.  What are the right operational choices that enable companies to take advantage of this volatility and stay ahead of their peers?  We will discuss the characteristics required for agile product supply, from line operations to network design.   The best of best practices from multiple companies will be profiled and shared during our discussion:

  • How did one pharmaceutical company take a risk-based approach to their network, seeking to understand sources of risk/volatility to root them out and remove them?
  • How did another pharmaceutical company define a management system of early warning indicators for their supply chain?  
  • How did another pharmaceutical company adopt lean best practices to enable more agile production operations?

Delegates will gain from this presentation: 

  • Understanding of best practices and lessons learned in managing supply and demand volatility
  • Perspective on some of the tools that can be employed to manage volatility

Speaker:

Andrew Gonce, Associate Principal in the Operations Practice, McKinsey & Company

Reliably Supplied – Catalent’s Operational Excellence Journey

Catalent Pharma Solutions is the Global Leader in drug development Solutions and advanced delivery technologies, for pharmaceutical, biologic and consumer health products.

We operate in the Business-to-Business (B2B) space, partnering with thousands of companies, including 49 of the top 50 pharmaceutical companies, 41 of the top 50 biotech firms, and hundreds of smaller innovators. We operate 25+ global sites with 8500+ employees serving 1,000+ customers in over 80 countries supplying 7000+ products.

We touched +75% of top-selling compounds and supported +50% of FDA approvals and are now working on 500+ new products.

Catalent’s brand promise, “More Products, Better Treatments, Reliably Supplied” drives our culture and actions.

In this presentation, Catalent will offer insight into how it delivers customer expectations throughout its business.

Speakers:

Luc Burgard, Director Operations, Catalent Pharma Solutions

Sridhar Krishnan, VP Global Operations, Catalent Pharma Solutions

Application of Operational Excellence Concepts in the Facility Design Process

Traditionally, in the Biopharmaceutical Industry as in other industries, Operational Excellence has been in use for quite some time to streamline manufacturing processes to reduce Cost of Goods. With the recent pressure on the Biopharmaceutical Industry to reduce cost of drugs, the industry is looking at all areas that impact the ultimate cost of drug products. Cost of Facilities making these drug products along with the operational costs and a few other cost elements required to produce drugs altogether termed as the “Total Cost of Ownership” has a significant effect on the cost of drugs. The Total Cost of Ownership concept heavily relies on OE concepts as applied to a facility and facility systems design. This presentation will focus on how to define, understand and apply OE concepts throughout the capital project design process. Adding OE to our capital project drivers presents some new challenges to capital project designers. The first one is actually defining the drivers and the respective metrics (so we can verify) that will provide assurance that we have the right design input to achieve the operational OE goals. This topic will describe how to define and obtain the respective skill sets and inputs needed on a progressive project timeline in order to account for the needed OE design inputs. The relevant experiences and skill sets that can present the right questions to the owner/user in order to understand which OE elements will be driving the design efforts may not be on the design team. This has created a need for a new SME or skill set in the design process.

This presentation will show the considerations needed in each design process phase (relative timeline) in order to incorporate the respective OE elements. In addition, some newer enabling manufacturing technologies that align with OE drivers will be presented for consideration.

Speaker:

Dave Goswami, CEO & Chairman, Integrated Project Services

Industry Transformation: The Next Generation of Operational Excellence

Traditionally, in the Biopharmaceutical Industry as in other industries, Operational Excellence has been in use for quite some time to streamline manufacturing processes to reduce Cost of Goods. With the recent pressure on the Biopharmaceutical Industry to reduce cost of drugs, the industry is looking at all areas that impact the ultimate cost of drug products. Cost of Facilities making these drug products along with the operational costs and a few other cost elements required to produce drugs altogether termed as the “Total Cost of Ownership” has a significant effect on the cost of drugs. The Total Cost of Ownership concept heavily relies on OE concepts as applied to a facility, facility systems design and turn over to operations. The Commissioning and Qualification activites are considered to be one of the most frustrating and impactful set of processes in the capital project. Historically, these processes have been seen and experienced as being too costly (value) and too elemental in causing delays to the start of manufacturing. This presentation will focus on how to define, understand and apply OE concepts throughout the commissioning and qualification process. Adding OE and Lean concepts to our capital project C&Q drivers presents some new challenges to C&Q stakeholders. This topic will describe how to define the respective skill sets and inputs needed on a progressive project timeline in order to account for the needed application of OE concepts. By applying the concepts of Lean into the C&Q processes, the ability to deliver project verification information at the best value (first quality at lowest cost) can be attained. The relevant experiences and skill sets that can present the right questions to the owner/user in order to understand how to apply these elements while maintaining “right-sized” compliance and driving out waste will be presented. This has created a need for a new SME or skill set in the overall C&Q process. The application of Risk Based approaches alone can present a jaded and “negative” perspective (avoidance) on attaining quality. By additionally applying the application of “who is the customer (perceiving the value)” and “value”, the C&Q processes can be “leaned out” to remove waste and provide first time quality with respect to project C&Q data.

This presentation will show the considerations needed in the C&Q processes in order to create a more focused and less wasteful C&Q output along with attaining faster facility turn over and meaningful documentation. Aligning the current Risk Based approaches with the Value Based OE drivers will be presented based on some recent implementations and examples of Risk Based approaches (ASTM E-2500-07 and ISPE Baseline Guides) at biopharmaceutical manufacturers. Additional considerations for how these applications can have impact on Total Cost of Ownership will also be covered.

Speaker:

Charles Stock, Sr. Vice President / Sr. Principal, Integrated Project Services

Operational Excellence in Quality Systems – Failures and Successes

‘OPEX’ is nothing new and has been energetically pursued by the pharma sector eager to ‘catch up’ other industries. Much has been said and done… but what has been the ‘return on investment’? With Consent Decrees, Warning Letters and other forms of regulatory censure hitting an all-time high one could argue the ‘OPEX’ is failing to deliver. Analysis of the regulatory action points to major failures in Quality Management Systems. This session will be provocative and stimulating in equal measure and provide answers to some key questions:

  • Why have Quality Management Systems become so complex?
  • Why have ‘OPEX’ principles failed to deliver measurable benefits to the very system designed to protect the patient… the Quality Management System?
  • How can we simplify our Quality Management Systems to make them more efficient at minimal risk?

Many companies have operationally inefficient Quality Management Systems that they can ill afford. Systems that increase risk as well as overheads. This session will challenge conventional thinking and help companies to make their Quality Management System a symbol of ‘Operational Excellence’.

Speaker:

Martin Lush, Vice President, NSF-DBA Ltd

Thank you to our Top Tier Sponsors

  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Official Media Partner
  • Media Partner
  • Follow ISPE

    ISPE Twitter Page ISPE Facebook Page ISPE LinkedIn Page