2013 Annual Meeting
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Program Schedule

Sunday, 3 November
13:30 - 17:00 Biomanufacturing
  • Leader: Jeffery Odum, CPIP, Director Ops, Biotech Lead, IPS, USA
  • Ali Afnan, PhD, President, Step Change Pharma Inc, USA
  • Peter Bigelow, President, XCell Strategic Consulting, LLC., USA
    If Single use is the answer, why isn't everyone using it?
  • Parrish Galliher, Chief Technology Officer, Upstream, Xcellerex LLC, USA
    The future of Biomanufacturing: Faster, Better, Cheaper
  • Joshua Hays, Associate Director of Upstream Business Development, EMD Millipore, USA
    If single use is the answer, why isn't everyone using it?
  • Paul Smock, Sr. Director, Technical Quality, MedImmune LLC, USA
    Biomanufacturing: Challenges for Controlled Non-Classified (CNC) Multi-Product Drug Substance Facility Design and Operation
  • Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA
    Bombs, Batteries or Baby Carriages: We can Learn from Other Industries
  • Thomas Warf, Chief, Infrastructure Branch, HHS/BARDA, USA
    HHS Centers for Innovation in Advanced Development and Manufacturing
13:30 - 17:00 New EU GMPs, Risk-MaPP and You • Are You Ready?
  • Leader: Stephanie Wilkins, PE, President, PharmaConsult US Inc, USA
    Setting Limits - EMA/Risk-MaPP Approaches Applying Health-Based Limits to determine if Dedicated Facilities are required
  • Nuha Al-Hafez, TEVA Canada, Canada
    Teva Global Quality Risk Management Program – Cross Contamination
  • Pamela Kelberer, EHS Officer, PII, USA
  • Joseph Payne, TEVA USA, USA
  • George Petroka, CIH, CSP, Principal, IES Engineers, USA
    QUANTIFYING CROSS-CONTAMINATION IN A MULTI-PURPOSE FACILITY: EXPERIMENTAL DESIGN AND INTERPRETATION
13:30 - 17:00 Best Practices for Single Use Technologies
  • Leader: Pietro Perrone, PE, Mobius Single-Use Sys Eng, EMD Millipore Corporation, USA
    Manufacturing Technology Track: Session 103 - Best Practices for Single Use Technologies
  • Ross Acucena, Regulatory Consultant, EMD Millipore, USA
    Best Practices in Qualification and Validation of Single-use Systems for Aseptic Final Filling - Presented by Ross Acucena and Christian Matz
  • Jean-Marc Cappia, Group VP Mktg Product Mgmt, Sartorius Stedim Biotech, France
    Extractable/Leachable Characterization Requires Material Science, Quality by Design & Supply Chain Control
  • Niels Guldager, CPIP, Senior Technology partner, NNE Pharmaplan A/S, Denmark
    ISPE Good Practice Guide for Disposables
  • Christian Matz, Global Project Manager, F. Hoffmann-La Roche Ltd, Switzerland
    Best Practices in Qualification and Validation of Single-use Systems for Aseptic Final Filling
  • Robert Munday, VP Technical Operations, CMC Icos Biologics, Inc., USA
    Implementation of Single Use Technologies
  • David Wolton, Biopharma Consultant, PM Group, Ireland
    Standardization of Disposables Design
13:30 - 17:00 Asset Reduction
  • Leader: Terry Jacobs, AIA, Partner, Jacobs Wyper Architects, LLP, USA
  • Sara Gates, Senior Interior Designer, Jacobs Wyper Architects, LLP, USA
  • Gualberto Medina, Executive VP Brokerage Svcs, CBRE Group, USA
    Repostioning of Life Sciences Office and Laboratory Spaces
  • William Wiederseim, President/CEO, PharmaBioSource, USA
    The State of the Industry-Too Much Space
13:30 - 17:00 The Use of Metrics in the Pharmaceutical Industry: A Practical Approach for Computerized System Compliance and Validation
Due to unforeseen circumstances, this session is CANCELLED. Handouts of presentations will be available after the conference.
  • Marc Monette, Consultant, Compliance Management Systems, Inc., USA
    Why Metrics Matter
  • Radouane Oudrhiri, Chief Technology Officer, Systonomy, United Kingdom
    Towards a General Framework for Developing Effective Metrics
13:30 - 17:00 Clinical Data and Systems
  • Leader: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems
  • Leader: Eric Staib, Senior Director IT Quality, RPS Strategic Solutions / A Division of PRA International, USA
    How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems
  • Jonathan Helfgott, Acting Associate Director for Risk, Science, Intelligence & Prioritization, FDA/CDER/Office of Scientific Investigations, USA, Invited
    Today’s FDA perspective on the role of electronic source data used in eClinical Systems
  • Frank Henrichmann, Technical Quality Manager, PAREXEL International, Germany
    Agile Project Management for Implementation of Regulated (GCP and GMP) Systems
  • Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    How to combine 21 CFR Part 11, EU-GMP Annex 11 requirements and how to apply these to local and global GCP systems
  • Marina Mangold, Head of EClinical Solutions & Data Management, Alcedis GmbH, Germany
    Agile Project Management for Implementation of Regulated (GCP and GMP) Systems
  • Maximilian Stroebe, QA eCompliance Manager, Novartis Vaccines, Netherlands
    Audit Trail Review in GCP and GMP Systems – A Regulatory Requirement?
  • Dieter Wachtmann, Sr Mgr Regulatory Intelligence, Parexel International, Germany
    Today’s FDA perspective on the role of electronic source data used in eClinical Systems
13:30 - 17:00 Project Execution in Emerging Markets
  • Leader: James Hamilton, Business Development, Fluor Corporation, USA
  • Thomas Hendricks, Vice President of Operations, Fluor Engineering & Construction Ltd, China
    Project Execution in Emerging Markets
  • John Hyde, Chairman & Founder, Hyde Engineering + Consulting Inc, USA
    State of the Art Biopharmaceutical Manufacturing in the Developing World
  • Niranjan Kulkarni, PhD, Operations Specialist, CRB Consulting Engineers, USA
    Designing a Lean Facility
  • Kristina Pumphrey, PE, Operations Specialist, CRB, USA
    Designing a Lean Facility
  • Josef Trapl, Tech Mgr Pharma-Medical Devices, M+W Group, Germany
    Advanced Facility Design in Emerging Markets
13:30 - 17:00 Institutionalizing the Process Improvement Mindset by Utilizing Operational Excellence
  • Leader: Elizabeth Zybczynski, Senior Manager, Baxter Healthcare Corp, USA
  • Prabir Basu, PhD, Consultant, USA
    What is Operational Excellence?
  • Richard Friedman, Assoc Dir., Off. Mfg & Product Quality, FDA/CDER/OMPQ, USA
    How QRM and Modernization Can Support Operational Excellence
  • Theodora Kourti, PhD, Senior Technical Director, GlaxoSmithKline, United Kingdom
    Leveraging PAT to enhance OpEx
  • Grace McNally, Senior Policy Advisor, FDA/CDER/OC, USA
  • Chris Stevenson, Sr Mgr Quality Inno. & Lifecycle Mgmt, Baxter Healthcare Corp, USA
    Implementation of Quality by Design (QbD) Concepts for a Legacy Immunoglobulin Product
13:30 - 17:00 Science-Engineering-Compliance: Essentials of GMP Manufacturing - A Young Professionals Track - Understanding Your Industry
  • Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA
  • Janet Bowen, VP Compliance Services, Commissioning Agents, Inc, USA
  • Timothy Fields, Vice President, Quality, Protein Sciences Corporation, USA
    Regulatory Concepts of Pharma, Medical Device and Biotech
  • Alice Redmond, Ph.D., Vice President, Commissioning Agents Inc, Ireland
    Manufacturing Techniques in Traditional and Biotech Facilities
  • Jonathan Romero, Associate Director Global Eng, Biogen Idec, USA
    Engineering Scale-up Challenges for Manufacturing Mammalian Cell System for producing Biologics
  • Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA
    Manufacturing Techniques in Traditional and Biotech Facilities
13:30 - 17:00 We the People: Managing People to assure Quality throughout the Project Management Lifecycle
  • Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  • Leader: James McGlade, Science Client Leader, BHDP Architecture, USA
15:00 - 15:45 Networking Break in Exhibit Hall
17:00 - 19:00 Sunday Welcome Reception in Exhibit Hall
Monday, 4 November
09:00 - 12:00 Plenary Session
2013 FOYA - Introduction of Category Winners and Announcement of the Overall Winner
  • Nancy Berg, President and CEO, ISPE, USA
    Strategic Direction for ISPE
  • Damian Greene, Global Network Strategy Leader, Zoetis, Belgium
    The Role of ISPE as a Global Organization
  • Julie Kim, General Mgr-BioTherapeutics, Baxter Healthcare Corporation, USA
    The Importance of the Baxter Covington Facility to the Industry and Patients
  • Janet Woodcock, Director, FDA/DHHS/Accounting Operations, USA, Invited
    Update on “Office of Pharmaceutical Quality,” What’s new in CDER and how it affects your process.
10:00 - 10:30 Networking Break
12:00 - 14:00 Lunch in Exhibit Hall
14:00 - 17:30 QbD and CPV for Biotech: How To Advance Implementation
  • Leader: Ranjit Deshmukh, PhD, Sr. Director, AstraZeneca, USA
    Industrial Case Study: Continued Process Verification (CPV) for Biotech Product (BPOG Collaboration)
  • Leader: David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
    Process Validation for Biotech Products
  • Ranjit Deshmukh, PhD, Sr. Director, AstraZeneca, USA
    Industrial Case Study: Continued Process Verification (CPV) for Biotech Product (BPOG Collaboration)
  • David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
    Process Validation for Biotech Products
  • Richard Gunderlock, Dir, Corp Validation Services, Astra Zeneca Global Ops Supply, USA
  • Stephen Tyler, Director Quality Assurance, AbbVie, USA
    Points to Consider for Process Validation for non-US regions
14:00 - 17:30 Individual Technical Presentations I - Cost-Saving Facilities Projects
  • Moderator: John Gilroy, PE, General Manager-CM, IPS, USA
    Integrated Project Delivery: Minimizing Risk and Reducing Overall Delivery Schedule and Costs
  • Vincent Cebular, Vice President, IPS, USA
  • John Gilroy, PE, General Manager-CM, IPS, USA
    Integrated Project Delivery: Minimizing Risk and Reducing Overall Delivery Schedule and Costs
  • Klaus Hermansen, Senior Technology Partner, NNE Pharmaplan A/S, Denmark
    Case study: Design of Vaccine Multiproduct facility - Challenges and Benefits!
  • Kiu Leung, Life Science Consultant, ProcessArc,
  • Vito Pirrera, Vice President of Operations, Vantage Consulting Group, USA
    Keys to Implementing a Successful Serialization Project
  • Shahbaz Shahbazi, Prinicpal, Process ARC, USA
    Product Complaint Investigations - The application of Lean Six Sigma methodology for U.S. FDA-Regulated Industries
  • Steve Shank, Senior Process Engineer, Process Plus, USA
  • John Wentz, P.E., Dir., Water/Wastewater Svcs, ProcessPlus,
    Wastewater Cost Savings by Design
14:00 - 17:30 Individual Technical Presentations II - Validation Trends
  • Moderator: Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?
  • John Fisher, President, Unidec, USA
    Extending the Life-Cycle of GMP Validated Legacy Systems
  • Oliver Herrmann, Principal Consultant, Q-FINITY Quality Management, Germany
    Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?
  • Martin Preis, Director, Tech Quality Mgmt, Parexel International, Germany
    Validation of Computerized Systems in a Global GCP Cloud: What can manufacturing and the GMPs learn?
  • James Schweitzer, Director, Commercial Technology Services, Vision Point Systems Inc., USA
    Lessons Learned from Validating a Cloud-based IRT system using the GAMP 5 Risk-based Approach
  • Luciano Tavares, Commercial Director, NNE Pharmaplan, Brazil
    Biotechnology Scenario on Brazilian Market
  • Connor White, Engineer I, USA
    Development of TOC Analytical Methods
14:00 - 17:30 Individual Technical Presentations III - Lifecycle Processes and Production
  • Moderator: Klaus Fritsch, Manager Compliance, Mettler Toledo AG, Switzerland
    GWP - The Scientific Global Standard for Risk-based Lifecycle Management of Weighing Equipment
    GWP® - The scientific global standard for risk-based lifecycle management of weighing instruments
  • Michael Anderson, Executive VP - COO, Total Facility Solutions, Inc, USA
    Collaborative Contracting for Project Success
  • Steve Buckingham, Engineer II, Hyde Engineering + Consulting Inc, USA
    Visual Image Processing for Bench Scale Cleanability Studies
  • Albert Dyrness, Vice President, ADVENT Engineering Services, Inc., USA
    Leveraging the ASME-BPE Standard for Compliance and Continuous Improvement
  • Klaus Fritsch, Manager Compliance, Mettler Toledo AG, Switzerland
    GWP - The Scientific Global Standard for Risk-based Lifecycle Management of Weighing Equipment
    GWP® - The scientific global standard for risk-based lifecycle management of weighing instruments
  • Frank Henrichmann, Technical Quality Manager, PAREXEL International, Germany
    Agile Project Management for Implementation of Regulated Systems
  • David Marks, P.E., President, DME Alliance Engineering Consultants, USA
  • Kelly Scalva, Engineer II/CORE Lab Lead, Hyde Engineering + Consulting Inc, USA
    Visual Image Processing for Bench Scale Cleanability Studies
14:00 - 17:30 "In Order to Form a More Perfect Project" - Managing Risk To Assure Quality throughout the Project Management Lifecycle
  • Leader: Brian Beck, Manager/TL Project Engineer, Zoetis Global Mfg and Supply, USA
  • Leader: Patricia Melton, BSc, MBA, PhD, Managing Director, MIME Solutions Ltd, United Kingdom
    PM Track: Sesseion 802 Exercise Handout
  • Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  • James McGlade, Science Client Leader, BHDP Architecture, USA
  • Alfred Penfold, Director, Global Engineering, Pfizer, United Kingdom
14:00 - 17:30 Executive Series - ISPE Research Initiatives
  • Leader: Michael Arnold, RPh, Sr. Dir., Strategic Partnerships, Invest. Prods, Pfizer Global Clinical Supplies, USA
    ISPE Research Initiatives
  • John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., United Kingdom
    Overview: ISPE's Drug Shortage Initiative
  • Kenneth Getz, Associate Professor, Tufts University Medical School Center for the Study of Drug Development, USA
    Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs)
  • Karleen Kos, Vice President of Member and Industry Services, ISPE, USA
    ISPE's 2014 Research Priorities
  • Christine Milligan, Global Director, Catalent Pharma Solutions, United Kingdom
    Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs)
  • Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
    Operations Team Update
  • Bryan Wright, ISPE Regulatory Advisor, WorkingWright Ltd, United Kingdom
    Outcomes from EMA Workshop on Drug Shortages
14:00 - 17:30 Executive Series - Baxter Facility Case Study
  • Leader: Brien Johnson, Vice President, Program Mgmt, Baxter Healthcare Corp., USA
    Saving and Sustaining Lives Worldwide
  • Leader: Jerald Polly, Principal, Flad Architects, USA
    Creating Solutions and Building the A/E Team
  • Samuel Kitchell, VP Engineering, Baxter Healthcare Corporation, USA
    Team Development
  • Ken Meschke, PE, Principal, Affiliated Engineers Inc., USA
    Creating Solutions and Building the A/E Team
  • Jerald Polly, Principal, Flad Architects, USA
    Creating Solutions and Building the A/E Team
  • Eric Schnake, Engineering Director, Baxter Healthcare Corp, USA
    Implementation: The Covington Site
  • Ryan Schroeder, Regional Leader, CRB Consulting Engineers Inc, USA
    Process Design & Innovation
  • Steven Shelden, Vice President of Operations, Yonkers Industries Inc, USA
    Construction
  • Scot Thomas, Program Director, Baxter Healthcare Corp, USA
    Implementation: The Covington Site
14:00 - 17:30 Executive Series - Facilities of the Future: Innovation, Standardization and Modularization
  • Leader: Pär Almhem, President, ModWave, USA
    Competing in a Global Market – Innovation, Standardization and Modularization
  • Mark Bell, Vice President of Operations, Gallus BioPharmaceuticals, LLC, USA
    The Future of Biologics Contract Manufacturing
  • Douglas Hausner, Assoc Dir. Business Dev Ind. Relations, Rutgers University, USA
    Continuous Solid Oral Dose Manufacturing
  • Detlef Kehm, PhD, VP, Maintenance and Engineering Services, Grifols Therapeutics Inc., USA
    Case Study: An Innovative Approach to Facilities Delivery
  • Robert Snow, CPIP, Senior Engineer Biologics Dev, Genzyme Corp a Sanofi Company, USA
    The Integrated Continuous Biomanufacturing Platform
14:00 - 17:30 Executive Series - Quality Metrics Outcomes: Conversations with FDA
  • Leader: Cynthia Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA
    Out of Specification / Laboratory Failure Investigation Rates
  • Diane Hagerty, Head of Global Quality Systems and Processes, Genentech, USA
  • Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA
    Quality Metrics Proposal: Batch Rejection Rate
    Quality Metrics a PQLI Initiative - Leading Indicators
  • Lorraine McClain, Sr Dir. Quality Compliance, Teva Pharmaceuticals, USA
    Quality Metrics Proposal: Batch Rejection Rate
    Quality Metrics a PQLI Initiative - Leading Indicators
  • Cynthia Salamon, VP, Global Quality Services, Bristol-Myers Squibb, USA
    Out of Specification / Laboratory Failure Investigation Rates
  • Lorraine Thompson, Quality Sys Implementation Dir, Novartis, USA
  • Russell Wesdyk, OPS Science Coordinator, FDA/CDER/OPS, USA
14:00 - 17:30 Science-Engineering-Compliance: Essentials of GMP Manufacturing - A Young Professionals Track - Integrating Quality Into Your Project
  • Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA
  • Nikolas Burlew, VP Quality Systems, Clinipace, Inc., USA
    Essential Elements of a Quality Management System
  • John Hannon, Vice President, SE Region, Commissioning Agents Inc, USA
    Effective Deployment of Information Management Systems
  • Michael Kimball, Executive Dir, Transdermal Dev, Actavis plc, USA
    Quality by Design
  • James Lambert, Baxter,
    The Structure of Risk Management
  • Dawn Tavalsky, Director, Genzyme Corp., USA
    Essentials of Process Validation including Case Studies
14:00 - 17:30 Investigational Products - Defining the New Landscape of Clinical Supplies: Share Industry Findings - Patient Survey
  • Leader: Michelle Foust, PharmD, Director of Supply Chain Strategy, Almac Clinical Services, USA
  • Kenneth Getz, Associate Professor, Tufts University Medical School Center for the Study of Drug Development, USA
    Patient Survey and Case Study Discussion: Findings and Implications
  • Michael Ku, PharmD, MBA, VP, Global Clinical Supply, Pfizer Inc, USA
    Patient-Focused Clinical Supply Supply Study
  • Christine Milligan, Global Director, Catalent Pharma Solutions, United Kingdom
    Patient Survey – A read out on the ISPE IP COP Survey on Patient Experience related to Investigational Medicinal Products (IMPs)
  • Robert Pizzie, PhD, Associate Vice President, Merck, USA
14:00 - 17:30 Maintenance and Reliability Programs and the Evolution into World Class Best Practices
  • Leader: Marie Getsug, CMRP, Director, Maintenance & Reliability Seervices, Commissioning Agents, Inc., USA
    FDA’s Perspective on Maintenance & Reliability Programs and the Evolution into World Class Best Practice
  • Michael Berkey, Reliability Engineer, Merck,
15:00 - 15:45 Networking Break in Exhibit Hall
19:30 - 22:00 YPREC-Young Professional's Event
Tuesday, 5 November
07:00 - 08:00 Quality Metrics Breakfast
08:00 - 11:30 Executive Series-The FDASIA Transition Point for Pharmaceutical Quality Systems (PQS) and cGMP
  • Leader: Joseph Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc, USA
    Benefits of Implementation for an Industry Standpoint of PQS, how quality systems informed the ISPE drug survey
  • Leader: Richard Friedman, Assoc Dir., Off. Mfg & Product Quality, FDA/CDER/OMPQ, USA
    FDA’s Next Steps for Quality Systems for Pharmaceuticals following FDASIA
  • Barbara Allen, PhD, Sr Director, Global Quality Sys, Eli Lilly SA, Ireland
    How management uses PQS to ensure consistent operations and reliable supply, and as a risk Mitigation strategy
  • Zena Kaufman, Sr. VP Global Quality, Hospira, Inc., USA
  • Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ, USA
    How FDA Communicates expectations for the Implementation of Quality Systems via its cGMP Inspection Compliance programs and via Regulatory Communications with Firms
08:00 - 11:30 "Establish plans to assure Project Tranquility" - Managing Project Initiation and Delivery Planning to assure Quality throughout the Project Management Lifecycle
  • Leader: John Honey, Head of Engineering, Roche, China
  • Leader: Alfred Penfold, Director, Global Engineering, Pfizer, United Kingdom
08:00 - 11:30 Managing and Assuring Quality
  • Leader: Alex Brindle, Ph.D., Managing Partner, NNE Pharmaplan, USA
  • Ferdinando Aspesi, VP, Sr Advisor To Group, USA
    Managing and Assuring Quality: From Development through Manufacture
  • Jean-Marie Geoffroy, Ph.D., VP Quality, Hospira, USA
  • Duncan Low, PhD, Scientific Executive Director, Amgen Inc, USA
    Eye of Newt and Toe of Frog – Understanding the Witches Brew of Raw Materials
  • Kelly Swinney, Associate Director, Vertex Pharmaceuticals, Inc., USA
    Developing Quality Assurance PAT Methods For Continuous Manufacturing and Real-Time Release
08:00 - 11:30 Advanced Aseptic Processing I
  • Leader: Ryan Hawkins, VP Ops - Chief Operating Officer, Cook Pharmica, LLC, USA
  • Leader: Jack Lysfjord, Principal Consultant, Lysfjord Consulting LLC, USA
    2012 Global Barrier Isolator Survey-Results and Trends
  • Hite Baker, Principal Process Engineer, DME Alliance Engineering Consultants, USA
    Isolation-Based Sterile Facilities: A Comparison of Conventional Stainless-Steel versus Single-Use-Disposable Technology Implementation
  • Sterling Kline, R.A., Vice President, IPS, USA
    Current Trends in Advanced Aseptic Processing Technology
08:00 - 11:30 FOYA I
  • Leader: Kelly Keen, Senior Project Manager, Genentech Inc., USA
  • Marcus Habluetzel, Senior Project Manager, F. Hoffmann-LaRoche Ltd, Switzerland
    FOYA Category Winner: Project Execution
  • Brent Hill, Director of Automation, AstraZeneca, USA
    UK Manufacturing Automation – A paradigm shift in the in the Egg based Vaccine Industry
  • Jack Kane, Associate Director, Project Eng, Biogen Idec, USA
    Flexible Volume Manufacturing Project, Biogen Idec
  • Mark Proctor, Director, MS&T, AstraZeneca, United Kingdom
    Redesigning Egg-based Bulk Vaccine Manufacturing
08:00 - 11:30 Data Integrity I: Ensuring Data Integrity throughout the Pharmaceutical Lifecycle
  • Leader: Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
  • Leader: Michael Rutherford, Consultant, Lab Systems, Eli Lilly & Co, USA
    The Importance of Data Integrity When Performing Data Reviews and Investigations
  • Jonathan Helfgott, Acting Associate Director for Risk, Science, Intelligence & Prioritization, FDA/CDER/Office of Scientific Investigations, USA, Invited
    Risk-Based Monitoring & eSource FDA Final Guidances
  • Karen Takahashi, Senior Policy Advisor, FDA, USA
    Assuring Data Integrity and Current FDA Enforcement Related to Data Integrity Problems
08:00 - 11:30 Lean Principles: QC Labs
  • Leader: Javier Garay, Principal-Architectural Designer, Flad Architects, USA
    Lean From a Design Perspective
  • Leader: James Gazvoda, Principal, Flad Architects, USA
    Lean From a Space Planning Perspective
  • Emilio Moia, Engineering Manager, Jacobs Italia S.p.A., Italy
    Lean From an Energy / Systems Perspective
  • Tom Reynolds, BSM, Ireland
    Lean in a Lab Environment
  • Pamela Thurtle, Div. Continuous Improvement Manager, Novartis, United Kingdom
    Incorporating Lean Principles into Pharmaceutical QC Laboratory Design:
08:00 - 11:30 Securing the Global Drug Supply Chain - Protecting Patients and Your Business
  • Leader: Brian Johnson, Sr Dir Supply Chain Security, Pfizer, USA
    Patients are Counting on Us: It’s Time to Act
  • Leader: Raymond Scherzer, PE, PM SET, LLC, USA
  • Thomas Christl, Acting Director, ODSIR, FDA, USA
    Challenges and progress in global supply chain security
  • Brian Johnson, Sr Dir Supply Chain Security, Pfizer, USA
    Patients are Counting on Us: It’s Time to Act
  • Peggy Staver, Director, Product Integrity, Pfizer Inc, USA
  • Tara Steketee, Assoc Dir, Product Integrity, Merck & Co Inc, USA
    Illegal Diversion of Pharmaceuticals
  • Timothy Valko, Executive Director, Operations Risk Management, Amgen Inc, USA
    Supply Chain Security Management System
08:00 - 11:30 PAT Based Process Control for Batch and Continuous Process - Ultimate Step in Real Time Release
  • Leader: Sharmista Chatterjee, PhD., QbD CMC Lead, FDA, USA, Invited
    Regulatory Considerations for PAT (Process Analytical Technology) based Control Strategy
  • Leader: Theodora Kourti, PhD, Senior Technical Director, GlaxoSmithKline, United Kingdom
  • Bryan Looze, Senior Engineer, Amgen, USA
    PAT-based Control on BioPharma
  • John Mack, Principal Engineer, Perceptive Engineering Ltd, United Kingdom
    PAT based Advanced Process Control and Monitoring applications for batch and continuous crystallization.
  • Robert Perks, MSc CEng, Engineering Specialist, Baxter Healthcare Corp, USA
    Manufacturing Tracking and Control Systems – State of the Art Practice for Parametric Release Sterilization Programs
  • Martin Warman, Senior Manager/Team Leader, Vertex Pharmaceuticals, USA
    Process Control in Continuous Processes
08:00 - 11:30 Regulatory Harmonization in Asia Pacific Countries - Challenges to Multi-National companies
  • Leader: Chi-wan Chen, PhD, Executive Director, Pfizer Inc., USA
    Session 209 Introduction
  • Min Gui, Assoc Director, Regulatory, Bristol-Myers Squibb Co., USA
    Challenges in New Drug Application (NDA)
  • Rebecca Komas, Dir CMC Advocacy-Strategy, GlaxoSmithKline, USA
    What's New with the Pharmacopeias?
  • Maurice Parlane, Principal/Director, New Wayz Consulting Ltd, New Zealand
    Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region
  • Xiling Song, Associate Regulatory Program Director, Genentech, A Member of Roche Grp, USA
    Recent Trends in Investigational Drug Application (IND) in Asia Pacific Countries
  • Susan Stolz, Principle Reg. Consultant, Eli Lilly & Co, USA
    Comparison of Asia Markets – Case Study for the Landscape in Post-Approval Changes/Variations
  • Robert Tribe, AP Reg. Affairs Advisor, ISPE, Australia
    Update on Good Manufacturing Practice (GMP) and PIC/S in the Asia Pacific Region
08:00 - 11:30 Process Validation: Bringing the Lifecycle Apporach to Practical Global Reality and Beyond
  • Leader: Joanne Barrick, R.Ph., Advisor, Global Validation, Eli Lilly & Co, USA
  • Gary Gamboa, Sr. Research Scientist, Eli Lilly, USA
  • Grace McNally, Senior Policy Advisor, FDA/CDER/OC, USA
    Implementation of Lifecycle Approach to Process Validation
  • Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA, Invited
08:00 - 11:30 Investigational Products - Defining the New Landscape of Clinical Supplies: Risk Management and the Supply Chai - Part I
  • Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA
  • Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA
  • Richard Gaeto, VP Corporate Operations, Dendreon Corp, USA
    From Autologous Cell Collection To Personalized Immunotherapy in 4 Days: Dendreon’s Supply Chain, A Case Study
  • Catherine Hall, Assoc Dir Clinical Operations, Biogen Idec, USA
    Driving the Last Mile toward Customer Focus in Clinical Trials
  • John Holland, Sr. VP-Research-Business Dev, AMC Health, USA
    Crowd Sourcing and Telemonitoing: "Better Data at Lower cost"
  • Darlette Luke, RPh, IDS Pharmacy Manager, University of Minnesota Medical Center Fairview,
    The Real World of IDS: Opportunity to Improve Process
  • David Northrup, Accenture Inc., United Kingdom
    Strategies in Controlling Risk in the Clinical Supply Chain
08:00 - 11:30 Science-Engineering-Compliance: Essentials of GMP Manufacturing - A Young Professionals Track - Critical Components To Successful Manufacturing
  • Leader: Joseph Manfredi, President, GMP Systems Inc, USA
    Facilities
  • Daniel Deese, PE, Mechanical Engineer, CRB Consulting Engineers Inc., USA
    Utilities - Energy saving options, case studies
  • Marcel Dion, Director of Marketing, STERIS Corp, Canada
    Principles of Steam Sterilization and Common Mistakes
  • Kevin Rawls, Auto System Integrator II, Avid Solutions Inc, USA
    Automation Applications in the Pharmaceutical Industry
09:15 - 10:00 Networking Break in Exhibit Hall
11:45 - 13:15 Membership Lunch
12:00 - 13:00 Exhibitor Lunch with Speaker
13:30 - 15:00 PHARMA CAFE-Cutting Edge Technologies
  • Leader: Nicholas Haycocks, Senior QA Specialist, Amgen Inc., USA
    The Pharma Cafe
  • Leader: Randolph Leinhauser, Associate Director, Engineering, Merck, USA
  • Bikash Chatterjee, President & CTO, Pharmatech Associates, USA
  • Oliver Stauffer, COO-VP Inspection Technologies, Packaging Tech & Inspection LLC, USA
    The Path to Package Integrity Non-Destructive Package Inspection Technologies
  • Carmine Stropoli, PE, Pharma Technology Director, Middough Inc, USA
    Non-Contact Measurement for Filled Weight Control
  • Randy Turner, Technical Director, Swan Analytical USA, USA
    TOC Innovations for Direct UV Oxidation in Pharma
13:30 - 17:15 Risk Based C&Q
  • Leader: Frank Van Der Steen, Owner/Principal Consultant, FVCS, Netherlands
  • Leader: Steven Wisniewski, Principal Consultant, Commissioning Agents, Inc., USA
  • Joerg Block, PS-TS-KM-Technical Compliance, Bayer HealthCare AG, Germany
    Risk Based C&Q for Standard Equipment Qualification in a Global 2-D Matrix Program
  • Machteld Deconinck, Principal Engineer, Johnson and Johnson, Belgium
    Lessons Learned about Planning
  • David Dolgin, Senior Quality Program Mgr, AbbVie Inc., USA
    Science and Risked Based C&Q
  • Nicholas Haycocks, Senior QA Specialist, Amgen Inc., USA
    Practical Application of a Risk Based Approach, and Lessons Learned
  • Brian Pochini, CPIP, Principal Engineer, Genzyme, A Sanofi Company, USA
  • Ghenet Simpson, Senior Central Engineer, Novartis Consumer Health Inc, USA
    Lessons Learned About Risk Assessment and Critical Aspects
13:30 - 17:15 Flexible API Manufacturing
  • Leader: Sarah Mancini, Senior Mgr, API Technology Lead, Zoetis, USA
  • Frank Gupton, PhD, Technical Director, Virginia Commonwealth University, USA
    Streamlining Pharmaceutical Processes into Continuous Operations
  • Patrick Kelleher, Sr Mgr-Team Leader Tech Lab, Pfizer, Ireland
    Flexible Scale Up in Pfizer One Approach Technology of the future
  • Michael O'Brien, Head Innovation-Tech Strategy, Pfizer Inc, USA
  • Bernhardt Trout, Ph.D., Professor-Chemical Eng Dept, MIT, USA
    Transforming Pharmaceutical Manufacturing to Continuous
13:30 - 17:15 FOYA II
  • Leader: Kelly Keen, Senior Project Manager, Genentech Inc., USA
  • Scott Billman, Director, Engineering, Novartis Vaccines & Diagnostics Inc., USA
    Advancing Vaccine Production for Pandemic Readiness
  • Robert Dick, PE, Principal, Precis Engineering, Inc., USA
    Sustainability: Winning Commitment to Sustainable Design
  • Sarah Fitzgerald, Associate Director, Global Eng Svcs, Merck, Ireland
    Operational Execellence: Building a Lean Structure for High Performance - Vaccine & Biologics Sterile Facility (VBSF)Carlow Ireland
  • Philip Sass, Ph.D., Executive Vice President/COO, Morphotek Inc, USA
13:30 - 17:15 Data Integrity II: Cloud Controls
  • Leader: Kathleen Gniecko, IT Quality Management Services Head, F. Hoffmann - La Roche AG, Switzerland
    Cloud Computing in GxP Environment - The Promise and Road to Clarity
  • Leader: Michael Rutherford, Consultant, Lab Systems, Eli Lilly & Co, USA
    Data Integrity GAMP Special Interest Group Launch
  • Monica Cahilly, President, Green Mountain Quality Assurance, LLC, USA
    Management Culture and Controls to Ensure Data Integrity when Out-Sourcing
  • Krishnakali Ghosh, CDER Compliance Officer, CDER/OC/OMPQ/DGMPA, USA, Invited
    Cloud Computing and Data Integrity – A Regulatory Perspective
  • Robert Streit, Sr Mgr Quality & Compliance, Johnson & Johnson, USA
    Data Integrity in the Cloud: The Promise, Reality and Road to Clarity
  • Anders Vidstrup, Senior IT Quality SME, NNIT A/S, Denmark
    Data Integrity in the Cloud: The Promise, Reality and Road to Quality
13:30 - 17:15 Master Planning Within the Pharmaceutical Industry
  • Leader: Dennis Romak, VP Food/Pharmaceutical Markets, Process Plus, USA
  • Steven Duckro, Senior Engineering Manager, Aptalis Pharmatech, USA
    Utilization of a Master Plan: Perspectives from Management & Engineering
  • Timothy Grinstead, Sr Director Mfg Ops-NA, Aptalis Pharma, USA
    Utilization of a Master Plan: Perspectives from Management & Engineering
  • Kenneth Popham, Senior Architect, Process Plus, USA
    Master Planning Processes
  • John Schlagetter, Senior Architect, ProcessPlus, USA
    Components of a Master Plan: Deliverables, Tools & Techniques
13:30 - 17:15 Quality Systems and the Cost of Non-Compliance
  • Leader: Rose Mary Dollard, Director, Johnson & Johnson, USA
    How to Make Your Quality System a Competitive Advantage: Effective Quality System Management
  • Eric Good, Vice President, Quality, KV Pharmaceutical, USA
    Quality Systems and the Cost of Non-Compliance
  • Tara Gooen, LCDR, PHS, Senior Advisor, FDA/ORA/Office of Policy and Risk Management, USA
    Putting the “Quality” in Quality Agreements for Contract Manufacturing Operations
  • Lisa Ray, Advisor-Distribution Center of Excellence, Eli Lilly and Company, USA
    Third Party Organization Management and Oversight: Evolution Requires Focus
13:30 - 17:15 Advanced Aseptic Processing II
  • Leader: Joerg Zimmermann, Dir Process Dev Implementation, Vetter Pharma Fertigung GmbH Co KG, Germany
  • Aarti Gidh, Investigator, GlaxoSmithKline, USA
    Product Impact study to Support Technology Transfer to a Commercial Isolator Enclosed Filling Line
  • Aaron Mertens, US Technical Manager, Atec Sterile Technology, USA
    Equipment Replacement with a Stopper Processing System
  • James Thompson, Senior Engineer, Amgen Inc, USA
    “The Right Tools for the Job”: Case study in Fill Process Scale-up of a Viscous, High Concentration Protein Product
  • Philipp Trojan, Groupleader QC Microbiology, AbbVie GmbH & Co., Germany
    Applying Quality Risk Management into Aseptic Manufacturing
13:30 - 17:15 Latin America Regulatory Compliance Forum
  • Leader: Gregory Gallegos, Sr Program Dir, Tech Regulatory, Genentech, USA
  • Leader: Marta Vidal, Marta Cicconi Vidal, Pharmaceutical Sciences Consultant, Angostura Salud SRL, Argentina
  • Stephen Colgan, Ph.D., Senior Director in Global CMC, Pfizer Global Research and Dev, USA
    Opportunities for Lean Stability Strategies
  • Eugenia Gotsis, Assoc Director, Reg. Affairs, Abbott Pharmaceuticals, USA
    Import Testing Requirements and Opportunities for Waivers
  • Rebecca Komas, Dir CMC Advocacy-Strategy, GlaxoSmithKline, USA
    Alternatives for Faster Approvals in Latin America
  • Birgit Unterladstaetter, Global Quality Manager, F. Hoffmann La Roche Ltd, Switzerland
    Challenges and Opportunities with Multi-Product Facilities for High Potent Drugs
13:30 - 17:15 Breakthrough Therapy—Are You Ready for Approval?
  • Leader: Eric Thostesen, Sr Dir-Strategic Bus. Support, Janssen Pharmaceutical Company Inc., USA
    Introduction to Breakthrough Therapy
  • Tara Gooen, LCDR, PHS, Senior Advisor, FDA/ORA/Office of Policy and Risk Management, USA
  • John Groskoph, Senior Director, New Products CMC, Pfizer, USA
    Risk Management Poitns to Consider CMC Planning for Small Molecule Product Launch Small Molecule
  • Brian Kelley, VP Bioprocess Development, Genentech Inc, USA
    Risk Management in CMC Planning for Breakthrough Therapies: Impact of Accelerated Launch in the Development Pathway for Large Molecules
  • Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA, Invited
  • Christine Moore, Ph.D., Acting Office Director, FDA, USA
  • Sarah Pope Miksinski, PhD, Director (Acting), Division of New Drug Quality Assessment, FDA/ONDQA/DNDQA 2, USA, Invited
    Successfully Moving Forward with IND and NDA Submissions for Breakthrough Drugs
  • Kelly Swinney, Associate Director, Vertex Pharmaceuticals, Inc., USA
    Continuous Manufacturing and PAT - Accelerating CMC Development for Breakthrough Therapies
13:30 - 17:15 Science-Engineering-Compliance: Essentials of GMP Manufacturing - A Young Professionals Track - Effective Project Leadership
  • Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  • Kenneth Ewan, Principal, KME Leadership LLC, USA
    Effective Project Leadership - Are you managing or are you leading - Understanding the distinction
  • Richard Gunderlock, Dir, Corp Validation Services, Astra Zeneca Global Ops Supply, USA
    Example of a worthy mission for a Biotech Project, The Merck-China hepatitis B Technology Transfer Project
  • Jerald Polly, Principal, Flad Architects, USA
    Baxter Case Study
  • Daniel Rouse, PE, Assoc. Director Project Eng, Novartis Vaccines, USA
13:30 - 17:15 Investigational Products - Defining the new Landscape of Clinical Supplies: Risk Management and the Supply Chain - Part II
  • Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA
  • Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA
  • Nicola Barnes, Director, Pfizer Ltd, United Kingdom
    An evolution - a patient and site focused approach to booklet label designs
  • Robert Scarth, VP and General Manager, Clintrak Clinical Labeling Services, USA
    Clinical Labeling Technology and Innovation
  • Paul Thomas, Chief Technical Officer, Clinigen Group, United Kingdom
    EU GDP - links to Clinical Trials
  • Terrence Walsh, Head, Comparator Network, TransCelerate BioPharma Inc, USA
    TransCelerate Introduction and The Comparator Network
13:30 - 17:15 "Provide for and promote a Project's General Welfare" - Managing Project Implementation to assure Quality throughout the Project Management Lifecycle
15:00 - 16:00 Networking Break in Exhibit Hall
19:00 - 22:00 Tuesday Party
Wednesday, 6 November
08:00 - 13:00 "Ensure the Blessings of Project Success" - Managing Project Closeout to Assure Quality throughout the Project Management Lifecycle
  • Leader: Keith Gibbs, Director of Project Delivery, Innovative Process Solutions, USA
  • Leader: Jeffery Odum, CPIP, Director Ops, Biotech Lead, IPS, USA
08:00 - 13:00 Investigational Products - Defining the New Landscape of Clinical Supplies: Labeling and Industry Updates
  • Leader: Neal Gordon, Ph.D., Director, Project Management, Merck, USA
  • Leader: Lorann Morse, SVP, Clinigen CTS, Clinigen, USA
  • Nicola Barnes, Director, Pfizer Ltd, United Kingdom
    Labeling Panel Discussion
  • Timothy Brewer, President, Yourway Transport, USA
  • Sandra Cook, PhD, President, Cook Consulting, USA
    The Blinding of Materials in Clinical Trials: Essential Processes for Ensuring the Integrity of Clinical Study Data
  • Matthew Gilson, Director Computer Systems QA, GlaxoSmithKline, USA
  • David Glynn, Sr Mgr New Prod. Planning, Sunovion Pharmaceuticals Inc, USA
    ISPE Update
  • Robert Scarth, VP and General Manager, Clintrak Clinical Labeling Services, USA
    The Future of Clinical Labeling
08:00 - 13:00 Current Regulatory Issues: QbD, Q7
  • Leader: Tara Gooen, LCDR, PHS, Senior Advisor, FDA/ORA/Office of Policy and Risk Management, USA
    Challenges to Inspection Readiness for QbD Applications
  • Leader: Roger Nosal, VP CGMC, Pfizer Inc, USA
    Industry Perspective of Evolution of Quality by Design In NCE Implementation
  • Betsy Fritschel, Director Quality & Compliance, Johnson & Johnson, USA
    Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development & Status
  • Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA, USA
    FDA Perspective of Improving Quality of Biopharmaceuticals
  • Lynne Krummen, Vice President, Genentech Inc, USA
    Biotech Lessons Learned from the Genentech and Roche QbD Journey
  • Christine Moore, Ph.D., Acting Office Director, FDA, USA
    ONDQA View on Implementation of QbD: Successes & Remaining Challenges
  • Alicia Mozzachio, RPh, MPH, Director Regulatory, FDA Interface Management Branch, USA
    ICH Q7:  Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q&A Development and Status
08:00 - 13:00 Integrating Risk Management as part of Process Development
  • Leader: Bikash Chatterjee, President & CTO, Pharmatech Associates, USA
    Integrating Risk Management as Part of Product, Process, and Quality System Development
  • Leader: Wai Wong, VP and GM Worldwide Ops, PharmaTech Associates, USA
    Introduction: Integrating Risk Management as Part of Product, Process, and Quality System Development
  • Brett Duersch, Associate Director, Chemistry, Merck & Co Inc, USA
    ICH Q9 Applied to Small Molecule Process Development, Scale-up and Implementation
  • Ian Leader, PhD, Product Dev Director, Shire Pharmaceuticals, United Kingdom
    Practical Risk Assessment for Process Design in a Virtual Development Environment
  • Vincent McCurdy, Ph.D., Head Operational Excellence, Pfizer Inc, USA
    Introduction to a Holistic Approach to Quality Risk Management of Product and Process Development
08:00 - 13:00 Stratefied Sampling Plans
  • Leader: Thomas Garcia, Research Fellow, Pfizer Inc, USA
    Introduction and the basis for the withdrawal of the draft guidance for industry "Powder Blends and Finished Dosage Units - Stratified In-Process Dosage
  • James Bergum, Ph.D., President, BergumSTATS, LLC, USA
    Sampling Plans and Statistical Methods for Process Validation
  • Karthik Iyer, Senior Policy Analyst, FDA/CDER/OC/OMPQ, USA
    Innovative Approaches to Assure Adequacy of Mixing
  • James Prescott, Senior Consultant/Director, Jenike & Johanson Inc, USA
    CU/BU Variations - How Far is Too Far? (By way of examples)
  • Ravi Tejwani, Senior Principal Research Scientist, Bristol-Myers Squibb, USA
    Relating blend uniformity specification to finished product
  • Alex Viehmann, Operations Research Analyst, FDA/CDER/OPS/SRS, USA
    FDA Recommendations Regarding In-process Sampling of Finished Dosage Units
  • Huiquan Wu, CDER/OPS/OTR/DPQR, USA
    Recommended Innovative Approaches to Ensuring Adequacy of Mixing of Powder Blends
10:15 - 10:30 Networking Break
13:00 - 14:00 Lunch
13:00 - 18:00 Manufacturing Facility Tour
    14:00 - 15:30 Global Regulatory Summit

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