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?"
Additional QSR resources:
Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
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