New Handbooks
| EU Medical Device Regulation 2017-745 |
| 21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
| Drug & Device GMP Desk Reference Set |
| 21 CFR 112 Produce for Human Consumption |
| 503B Compounding Master Guide |
| GMP International Master Reference Guide |
| 21 CFR 320 - Bioavailability and Bioequivalence Requirements |
| 21 CFR 115 and 118 Egg Products |
| ICH Q7, Q8(R2), Q9(R1), Q10 and Q11 |
| Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT |
| In Vitro Diagnostics 2017/746 Medical Devices |
| Dietary Supplement Master Handbook |
| GMP Medical Device Master Reference Guide |
| FDA DEA GMP Master Reference Guide |
| 21 CFR 4 - Regulation of Combination Products |
| ICH Q7 with Q7 Auditors Check List |
| In Vitro Diagnostics Master Handbook |
| VICH GL9 Animal GCP |
| Title 21 CFR Parts 1 - End Nine Volume Set |
| 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R3) - Good Clinical Practice Handbook |
| 21 CFR 50, 54, 56 - GCP Drug Approval Handbook |
| 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination |
| 21 CFR 50 - Protection of Human Subjects |
| 21 CFR Part 117 - Food GMPs |
| ICH Q12 Pharmaceutical Product Lifecycle Management |
| 21 CFR Part 207 Registration |
| 21 CFR 117 - cGMPs for Human Food - ENGLISH/SPANISH |
| EU cGMPs for ATMP with EU GMP Chapters 1-9 and Annexes 1, 8, 11, 13, 14, 15, 16 & 19 |
| GLP Manufacturing Handbook - 4.5x7.5 |
| 21 CFR 112 - Produce for Human Consumption - ENGLISH/SPANISH |
| GLP Analytical Stability Handbook - 4.5x7.5 |
| Canadian - SOR98-282 Medical Devices Regulations |
| 21 CFR 112 - Produce for Human Consumption - SPANISH |
| 21 CFR Parts 112 and 117 - ENGLISH/SPANISH |
| EU cGMPs for ATMP with EU GMP Chapters 1-9 |
| ICH Q2(R2) and ICH Q14 Analytical Validation |
| GCLP Good Clinical Laboratory Handbook - 4.5x7.5 |
| US FDA, Canadian and European MDR |
| 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
| 21 CFR 112 with Guidance for Industry 2024 |
| 21 CFR Part 112 Produce and 117 Food GMPs |
| EU cGMPs for ATMP - 2018: Guidelines on Good Manufacturing Practice Specific to Advanced Therapy Medicinal Products |
| ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination |
| Standard Sterile Product Manufacturing Handbook |
| 21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024 |
| Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs |
| Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14 |
| GMP Manufacturing Handbook |
| GMP Training, Certificate, GMP Handbook & e-Workbook |
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