Yesterday we talked about FDA 483 Warning Letters and CAPA .
Ensuring that your CAPA system meets the FDA requirements can be complex if you rely on guesswork or if you try to memorize all the regulations relating to CAPA that the FDA publishes. Here is a simple 10 step checklist to help ensure that you have covered all the essentials. 1. Verify that you have documented all procedures.
To prevent misunderstandings or inconsistencies, documentation should include management-supported definitions...(read more)![]()
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