LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Let's Talk Risk! Podcast
- Published
- August 29, 2025
- Duration
- 1:09
- Summary source
- description
- Last updated
- Jul 5, 2026
Discusses This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“D…
Summary
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discus…
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Show notes
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day they walk through your door.” In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal and Michelle Lott from Lean RAQA discuss the upcoming Quality Management System Regulation (QMSR) for medical devices, emphasizi…