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LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
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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By Casual and informal conversations about practical aspects of medical device risk management.
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22 ratings
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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