LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections
Let's Talk Risk! Podcast
- Published
- May 8, 2026
- Duration
- 38:51
- Summary source
- description
- Last updated
- May 10, 2026
Discusses Summary“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions a…
Summary
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…
Show notes
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 i