FDA Audit Preparation - Audit Theory - Be Ready

This Pharma Compliance Blog post, The Role of Affect in your Culture of Compliance, resonates with me. I think in principle, the core idea about being prepared for audits, extends well beyond GMP regulated industries. The takeaway for me is, of course your paperwork needs to be in order, AND your people have to prepped from an emotional and behavioral standpoint.

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21 CFR Part 820 QSR Audit Checklist - Are you ready?
Free 21 CFR Part 820 QSR Audit Checklist

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Surviving an FDA Inspection - a training course by SkillsPlus International Inc.

This class prepares plant personnel to participate in an FDA Inspection.

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