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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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