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GAMP 5 AI: FDA Enforcement Actions 2024–2025
What four FDA warning letters mean for your QA team in 2026 — and the specific documentation every pharma AI system needs before the next inspection.
Date
April 2026 — Date TBC
Duration
45 minutes
Format
Live online · Replay available
Cost
Free
Agenda
- Overview of all four FDA AI warning letters (2024–2025)
- The most common finding: post-hoc acceptance criteria
- Model version control: what inspectors expect to see
- The six-document AI inspection package
- Live Q&A with a GxP AI specialist
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