ISPE NJ Presents GAMP 5 -2nd Edition: Changing the Narrative
Sponsored by: Apprentice.io & 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
AGENDA
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 Apprentice.io
- AI/ML Validation Approaches: Eric Staib, Head of Quality at Validated Cloud
Panel Discussion
Cocktails and Tech Show & Tell
Registration
- Members $50
- Non-Members $75
- Emerging Leaders $40
- Students FREE
REGISTER HERE
Coming Events 2023 Golf Outing May 15 REGISTER HERE