Process Validation Conference, 12 -14 September 2017, Bethesda Marriot, Bethesda, MD

Education Program

Industry and regulatory experts convene to bring you the latest developments for implementing an effective process validation system at the 2017 Process Validation Conference

Benefit from technical content designed to:

  • Focus on sustaining continued evolution of a scientifically sound lifecycle approach to Process Validation
  • Define the requirements and best practices in the light of regulatory expectations for the effective implementation of Process Validation 
  • Create an understanding of sources for process variability, process parameters, and their impact on product quality
  • Demonstrate the use of statistically derived sampling plans and acceptance criteria
  • Show how to maintain an on-going process monitoring once the initial process validation study has been completed

Featured Sessions will include: 

  • Keynote: PPQ of Large Molecules: FDA Perspective, US FDA
  • Keynote: Stage 3 PV and Quality Risk Management Procedures: ICH Q9, US FDA
  • Acceptance Criteria and Sampling in a Lifecycle Approach to PV, AbbVie Inc.
  • Case Study: Packaging Validation Lifecycle, Bristol-Myers Squibb
  • Process Validation in the Context of Continuous Manufacturing Processes, Eli
    Lilly & Co. 
  • OPV Process and Decision Making for Large Molecule Product, Eli Lilly & Co.
  • Workflows for Criticality Assessment during PV Stage 1, Exputec, GmbH
  • Recommended Approaches for Stage 1-3 Rollout, GSK
  • PV for Accelerated and Breakthrough Programs, Merck & Co. 
  • Statistical Case Studies on Application and End-result, Shire

Schedule at a Glance

Tuesday, 12 September 2017

08.30–10.00 General/Keynote Session
10.00–10.30 Networking Break
10.30–12.30 Education Sessions
12.30–13.30 Lunch
13.30–15.00 Education Sessions
15.00–15.30 Networking Break
15.30–16.30 Interactive Exercise
16.30–17.15 Education Sessions

Wednesday, 13 September 2017

08.30–10.00 General/Keynote Session
10.00–10.30 Networking Break
10.30–12.30 Education Sessions
12.30–13.30 Lunch
13.30–15.00 Education Sessions
15.00–15.30 Networking Break
15.30–16.30 Interactive Exercise
16.30–17.30 Education Sessions
17.30 - 18.30 Combined Networking Reception
18.30 - 20.00 Concurrent Evening Sessions

Thursday, 14 September 2017

08.30–10.00 Combined Regulatory Sessions for Attendees of Both Conferences
10.00–10.30 Networking Break
10.30–12.00 Combined Regulatory Sessions for Attendees of Both Conferences
13.00 Conference Adjourns

 

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Presentations & Attendee Roster

Conference Attendees: