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21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook
21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook
SKU:978-1-935131-29-8
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US FDA Title 21 CFR Parts
- Part 11 - Electronic Records/Electronic Signatures (ERES)
- Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
- Part 820 - Quality Systems Regulations
Auditor's Check Lists
- Part 11 Electronic Systems Auditor's Checklist
- Pharmaceutical GMP Auditor's Checklist
-
Medical Device Quality Systems Regulation Auditor Checklist
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