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FDA DEA GMP Master Reference Guide

FDA DEA GMP Master Reference Guide

SKU:978-1-935131-57-1

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US FDA Title 21 CFR

  • Part 11 - Electronic Records; Electronic Signatures
  • Part 11 - Electronic Records; Electronic Signatures - Scope and Application 2003
  • Parts 210/211 - Drug GMPs
  • Part 1301 - Sections 71-77 Security and Sections 90-93 Employee Screening
  • Part 1302 - Labeling and Packaging Requirements for Controlled Substances
  • Part 1304 - Records and Reports of Registrants
  • Part 1305 - Orders for Schedule I and II Controlled Substances
  • Part 1316 - Administrative Functions, Practices and Procedures
  • Part 1317 - Disposal
Auditor's Checklists:
  • Part 11 - Electronic Records; Electronic Signatures Audit Check List
  • Parts 210/211 - Drug GMP Audit Check List
  • Controlled Substances GMP Audit Check List

 Guidance

  • ICH Q9 - Quality Risk Management
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