Tuesday, December 2, 2008

Think Like An FDA Inspector - Be Prepared


Yep, it's important to follow all the regulations. AND, it helps to understand how the FDA inspector will approach your company during an inspection. On the FDA website, several free documents are published as reference material for investigators and other FDA personnel. The documents don't bind the FDA and don't confer any rights, privileges, benefits or immunities for or on any person(s). Basically, they'll help you prepare and anticipate what to expect from an FDA inspector and inspection team. Just be forewarned, it also means that they don't have to follow the suggestions or recommendations mentioned in the inspection guides. Here's a listing of the major categories of inspection guides that are available . . .

Biotechnology
Biologics
Computer Issues
Devices
Drugs
Foods Cosmetics
Miscellaneous

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