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

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

SKU:978-1-935131-46-5

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Master GMP Trainer - 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 GMPs for the 21st Century - A Risk Based Approach (2004)
  • Quality Systems Approach to GMPs (2006)
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