New Handbooks
EU Medical Device Regulation 2017-745 |
21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals |
21 CFR 11, 110, 117, 120 - Food GMPs |
Drug & Device GMP Desk Reference Set |
21 CFR 112 Produce for Human Consumption |
503B Compounding and Packaging |
GMP International Master Reference Guide |
21 CFR 320 - Bioavailability and Bioequivalence Requirements |
21 CFR 115 and 118 Egg Products |
ICH Q7, Q8, Q9, 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 |
21 CFR 11, 820 QSR and 830 UDI |
FDA DEA GMP Master Reference Guide |
21 CFR 4 - cGMP for Combination Products |
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master |
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 Part 117 - Food GMPs |
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 |
21 CFR 112 - Produce for Human Consumption - ENGLISH/SPANISH |
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 |
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 |
Clinical Manufacturing Handbook |
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