New Books and Updated Parts - 2024!
21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
Updated 2024 - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook |
Updated 2024 - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination |
Updated 2024 - 21 CFR 50 - Protection of Human Subjects |
Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook |
ICH Q2(R2) and ICH Q14 Analytical Validation |
21 CFR Part 121 Mitigation Strategies |
21 CFR Part 207 Registration |
Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs |
Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14 |
Canadian - SOR98-282 Medical Devices Regulations |
Standard Sterile Product Manufacturing Handbook |
EU GMPs with Annex 1 Sterile Medicinal Products |
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