2012 Process Validation, 17 - 18 October, Silver Spring, MD

Program Agenda

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Wednesday, 17 October
09.00 – 09.45 Session Introduction – Objectives and Structure; Lifecycle Basics, Interactive Polling/Benchmarking Questions

Joanne Barrick, Lilly
09.45 – 10.30 Expectations/Deliverables from Process Validation Stage 1 (Process Development), Criticality, Design Space and Control Strategy

John Lepore, Merck (Invited)
10.30 – 11.00 Networking Break
11.00 – 12.00 FDA View of Lifecycle Approach Implementation Status and Application to Legacy Products, Including 15 minutes of Question and Answer Session

Grace McNally, FDA
12.00 – 12.30 Foundation for Process Validation Acceptance Criteria- Applying Quality Risk Management to Control Strategy

Anne Renton, Lilly
12.30 – 13.30 Lunch
13.30 – 14.30 PPQ (PV Stage 2) - Statistically Based Process Validation Acceptance Criteria Determination - Including Example Approaches

Mark Varney, Abbott
14.30 – 15.00 Acceptance Criteria Approach - Small Group Exercise with Whole Group Wrap Up Session

All Speakers
15.00 – 15.15 Networking Break
15.15 – 15.45 Acceptance Criteria Debrief
15.45 – 16.30 IMB/EMA View of Process Validation Lifecycle Approach and Objectives and Impact of EMA Process Validation Draft Guidance

TBD
16.30 – 17.00 Benchmarking Questions for the Group and Additional Q&A with Regulators
17.00 Evening Reception
Thursday, 18 October
07.30 – 08.30 Breakfast
08.30 – 09.05 Using Science and Risk Assessment - Control Strategy and Variability Impact on Process Validation Plan

Dave Dolgin, Abbott
09.05 – 09.45 PPQ – Stage 2 – Statistically Based Sampling Plans

Mark Varney, Abbott
09.45 – 10.15 Determining a Process Validation Sampling Plan - Small Group Exercise

All Speakers
10.30 – 11.00 Networking Break
11.00 – 11.30 Exercise Debrief and Discussion
11.30 – 12.00 Determining the Number of Process Validation Batches - General Considerations and an Example Approach, Based on ISPE Process Validation Subteam work. Making the Batch Release Decision Based on Stage 1 and Stage 2 Data.

Jeff Fleming, Pfizer
12.00 – 12.45 Determining Number of Batches Exercise or Additional Discussion, Questions on Draft Discussion Document

All Speakers
12.45 – 13.45 Lunch
13.45 – 14.20 Process Validation Stage 3 – Post PV Continued Monitoring

Kurtis Epp, BioTechLogic (Invited)
14.20 – 15.05 Determining Process Validation Stage 3 Plan Exercise and Debrief and Questions on Draft Discussion Document

All Speakers
15.05 – 15.35 Break
15.35 – 16.05 Managing the Post Process Validation Plan and Incorporation in Quality Systems. "Turning Off and On Heightened Monitoring."

Joe Famulare, Genentech/ Roche
16.05 – 16.35 Breakout Sessions and Benchmarking Opportunity:
  • Opportunity to offer comments on draft EMA PV Guidance
  • What Are Remaining Issues and Challenges?
  • Future direction for ISPE PV Teams? Next Discussion Paper Topics?
All Speakers
16.35 – 17.00 Breakout Session Summaries and Panel Response

All Speakers