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

Education Program

Join Experienced Statisticians at 2017 Process Validation Statistics Conference

  • Comprehensive forum for statisticians and those skilled in the use of statistics, to explore the merits and challenges of existing and new statistical approaches
  • State-of-the-art approaches to implementing statistical elements that support the lifecycle approach to Process Validation
  • Exceptional opportunity to experience current best practices in the use of statistics for lifecycle process validation, reflect on past practices, examine current trends, and explore future challenges

Featured sessions include:

  • Analytical Quality by Design (AQbD) in Pharmaceutical Development, Pfizer Inc. 
  • A PV-1 Statistical Approach to Aid Process Parameter Criticality Assignment, Pfizer Inc. 
  • Generics – Challenges with Failure to Be IID, Cook Pharmica
  • End-to-End Risk Assessment Strategy for Multi-Stage Processes in the PV Lifecycle: Applying Statistical Approaches Commensurate with Business Risks, Bristol-Myers Squibb 
  • PPQ Sampling Plans and Bayesian Tolerance Intervals Using R-Shiny, Janssen Pharmaceuticals
  • Statistician’s Perspective on Contract Manufacturing, Shire

Schedule at a Glance

Wednesday, 13 September 2017

17.15–18.15 Combined Reception for Attendees of both Conferences
18.15–19.45 Concurrent  Evening Sessions for Attendees of both Conferences

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
12.00–13.00 Lunch
13.00–14.30 General/Keynote Session
14.30–15.30 Education Sessions
15.30–16.00 Networking Break
16.00–17.30 Panel Discussion

Friday, 15 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
17.15 Conference Adjourns

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Presentations & Attendee Roster

Conference Attendees: