Saturday, September 20, 2008

Free 21 CFR Part 820 QSR Audit Checklist

FDA Guide to Inspections of Quality Systems


Updated February 13, 2021

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FDA - Guide to Inspections of Quality Systems

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Don't be caught flat-footed, be ready for the FDA. "Highlight any compliance gaps in your quality management system with a comprehensive FDA GMP Checklist...," says Chris Scholl Consulting Associates. On their site, they offer a free checklist, "21 CFR 820 Audit Checklist." If you don't know where or how to start, they suggest a couple of things to think about, "Are You Ready for the FDA?"

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