LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections

Podcast: Let's Talk Risk! Podcast · Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Opublikowano: 2026-05-08

Summary “FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.” In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about what early FDA 483 observations under QMSR are already revealing: a clear shift from procedural compliance to evaluating how well companies actually make risk-based decisions across their quality systems. This conversation goes beyond clauses and documentation. It explores how FDA is now looking at system effectiveness, how risk must be integrated across the full product lifecycle, and why leadersh...