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A risk-based approach to CAPA: Insights for QMSR transition with Darrin Carlson

CAPA continues to be the top issue in FDA warning letters. It's time to start thinking about applying a risk-based approach as you plan your transition to QMSR.

Summary

“A risk-based approach, however you define it, is very critical .”

In this episode, Darrin Carlson emphasize the need for developing a risk-based approach to key processes of your Quality Management System (QMS), including the Corrective and Preventive Action (CAPA) process.

CAPA process continues to be the top issue in FDA warning letters. As you…

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