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GAMP 5 - 2nd Edition: Changing the Narrative

ISPE NJ Presents GAMP 5 -2nd Edition: Changing the Narrative

Sponsored by: & Compliance Path an Ideagen Company

This GAMP Forum will focus on some of the key changes to GAMP 5, and the draft CSA guidance from FDA with an emphasis on how technology and contemporary thinking are converging to increase patent safety and product quality via the application of critical thinking.

Tuesday, June 13, 2023
1:00 PM - 5:00 PM
5:00 PM Cocktail Reception

Apprentice HQ

101 Hudson Street

38th Floor

Jersey City, NJ 07302

Complimentary Parking


Opening Remarks

  • GAMP 5 2nd Edition & 21 CFR part 11: Sion Wyn, Director at Conformity Ltd.
  • What is CSA?: Lorrie Schussler, Chair, GAMP Americas Steering Committee
  • Critical Thinking - let's do some: Stephen Ferrell, VP IT Governance & Software Assurance, CompliancePath Limited
  • CSA/GAMP - from SaaS Perspective: Michael Martone, Director of Quality at
  • AI/ML Validation Approaches: Eric Staib, Head of Quality at Validated Cloud

Panel Discussion

Cocktails and Tech Show & Tell


  • Members   $50
  • Non-Members $75
  • Emerging Leaders $40
  • Students    FREE 


Coming Events 2023 Golf Outing May 15 REGISTER HERE