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21 CFR 801 - Labeling - Medical Device
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21 CFR 205 - Guidelines for Licensing of Wholesale Drug
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21 CFR 112 - ENGLISH/SPANISH
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21 CFR 110, 117, 130, 131, 133 - Milk and Dairy
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21 CFR 117 - GMPs for Human Food - ENGLISH/SPANISH
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21 CFR 11, 210/211 with Keyword Index
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2023 National Conference on Interstate Milk Shipments (NCIMS) 4 Book Set
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MHRA, EU & ICH GMP Handbook
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21 CFR Part 821 Medical Device Tracking Requirements
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21 CFR Part 860 Medical Device Classification Procedures.
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ICH Q7 with Q7 Auditors Check List
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ICH Q2(R2) and ICH Q14 Analytical Validation
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ICH Q12 Pharmaceutical Product Lifecycle Management
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ICH M10 Bioanalytical Method Validation
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EU GMPs with Annex 2 Biological
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EU GMPs with Annex 15 Qualification and Validation
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21 CFR Parts 112 Produce and 117 Food GMPs
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Canadian - SOR98-282 Medical Devices Regulations
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EU cGMPs for ATMP with EU GMP Chapters 1-9 and Annexes 1, 8, 11, 13, 14, 15, 16 & 19
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EU GMPs Chapter 1 - 9
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EU GMPs with Annex 11, 15, 16, 18, 19
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21 CFR 814 - Premarket Approval of Medical Device
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21 CFR 812 - Investigational Device Exemptions
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21 CFR 810 - Medical Device Recall Authority
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