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FDA Regulations:

21 CFR Part 211 cGMP’s for Drug Products

 

21 CFR Part 610 cGMP’s for Biologics

 

21 CFR Part 820 cGMP’s for Devices

 

21 CFR Part 58 cGMP’s for Good Laboratory Practice for Nonclinical Laboratory Studies

 

21 CFR Part 11 Electronic Records; Electronic Signatures

 

21 CFR Part 7 Enforcement Policy

 

 21 CFR Part 3 Product Jurisdiction