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LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR

LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR

Update: 2025-08-29

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This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.com

Summary

“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…

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LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR

LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR

Casual and informal conversations about practical aspects of medical device risk management.