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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