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 1–3 of 4 episodes
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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 3 · Deviation Closure
The Deviation Was Closed. The Problem Wasn't.
Samantha and Alex examine two FDA warning letters from September 2026, Fresenius Kabi and Baxter, and the deviation closures that looked complete until FDA read them.
Listen · 21 min 8 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