The Record Behind the Decision
The Podcast for Real GMP Decisions
Conversations with quality and compliance leaders about consequential decisions, the reasoning behind them, and what they mean in practice.
Listen to the Latest EpisodeHosted by Samantha and Alex.
Showing 1–2 of 2 episodes on CAPA Effectiveness
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Episode 4 · CAPA Effectiveness
How Do We Know It Worked?
Samantha and Alex examine what a CAPA closure has to prove, and why a signed task list is not proof.
Listen · 21 min 1 sec -
Episode 2 · CAPA Effectiveness
CAPA Effectiveness: Two Warning Letters, One Failure
Samantha and Alex examine two November FDA warning letters and what makes a CAPA record hold up — the shared quality-unit failure, the CAPA pattern, and the six questions a CAPA record has to answer.
Listen · 20 min 7 sec