2013 Process Validation Compliance Conference

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Event Schedule

Wednesday, 9 October
08:30 - 09:00 Introduction: PV Lifecycle Basics and the Importance of Variability; ISPE PQLI PV Team Activities; Interactive Benchmarking
09:00 - 10:00 Statistically Determined Acceptance Criteria and Sampling Plans for PPQ
  • Mark Johnson, Principal Research Statistician, AbbVie Inc., USA
10:00 - 10:30 Networking Break
10:30 - 11:15 Group Exercise: Determining PPQ Criteria and Sampling Plan
    11:15 - 12:00 Expectations/Deliverables From PV Stage 1- Process Understanding, Control Strategy, Variability - Case Study
    12:00 - 13:00 Lunch
    13:00 - 14:00 Case Study: Application of Lifecycle Approach to PV to Large Molecule Parenteral Product
    14:00 - 14:30 Statistical/Risk Based Means to Determine the Number of PPQ batches-ISPE PQLI PV Team Discussion Paper Approaches
    14:30 - 15:15 Networking Break
    15:15 - 16:15 Exercise: Determining the Number of PPQ Batches
      16:15 - 16:45 PV Expectations Outside USA
      17:00 - 18:30 NETWORKING RECEPTION
      18:30 - 21:00 RUTGERS TOUR
      Thursday, 10 October
      08:00 - 08:45 Use of ASTM E2709 and 2810 for Validation and Release
      08:45 - 09:30 Exercise: Applying USP limits and ASTM Standards to a Data Set
      • Facilitator: James Bergum, Ph.D., President, BergumSTATS, LLC, USA
      09:30 - 10:15 Case Study: Applying Different Statistical Approaches for Same Data Set - Impact on PV Results (ISPE Discussion Paper)
      10:15 - 10:45 Networking Break
      10:45 - 11:15 Impact of Lifecyle Approach on Legacy Products- Case Study
      11:15 - 12:00 Challenges in Implementing the Lifecycle Approach to PV for Generic Manufacturing
      • Markus Kiefer, Ph.D., Head Manufacturing Science & Technology, Sandoz AG, Global Technical Operations, Switzerland
      12:00 - 12:30 Panel Discussion - Most Difficult Challenges to Lifecycle Approach Implementation
      12:30 - 13:30 Lunch
      13:30 - 14:00 Application of Lifecycle Approach to PV to Large Molecule/Biologics Processes (ISPE Discussion Paper)
      14:00 - 14:45 PV Stage 3 - Making PV Stage 3a Decisions
      14:45 - 15:15 Networking Break
      15:15 - 16:00 Determining a Stage 3a Decision
      16:00 - 16:30 Business Benefits of Using a PV Lifecycle Approach - Return of Investment Model
      • Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA
      16:30 - 17:00 Next Actions, Benchmarking Opportunity, Remaining Issues and Challenges, Future Discussion Topics
      • Joanne Barrick, R.Ph., Advisor, Global Validation, Eli Lilly & Co, USA
      • Jenn Walsh, Associate Director Mfg Tech, Bristol-Myers Squibb, USA

       

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