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GMP Publications - Code of Federal Regulation Handbooks by the FDA

21 CFR 11, 58, 210/211, 820 - Master GMP Trainer

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978-1-935131-46-5

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES) with Scope and Application
Part 58 - Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
Part 820 - Quality Systems Regulations

Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach (2004)

Quality Systems Approach to GMPs (2006)

















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