Collection: All Publications
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21 CFR 809 - In-Vitro Diagnostic Products
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21 CFR 640 - Add. Standards for human blood and blood products
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21 CFR 112 with Guidance for Industry 2024
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21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
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21 CFR 11, 110, 117, 120, 123 - GMPs for Fish Industry
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21 CFR 11, 110, 112, 117, 120 - Produce cGMPs -
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21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist
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2023 NCIMS – Methods for Making Sanitation Rating of Milk Shippers
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Master Reference Desk Set - Drug, Dietary & Medical Device
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21 CFR Parts 210/211 with EU Annex 1
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Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
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Medical Device Quality Systems Manual with 820 and QMSR Audit Checklist
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Medical Device QSIT Manual with 11 and 820
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Japanese GMP for Drugs and Quasi-drugs - 2005
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ICH Q7, Q8(R2), Q9(R1), Q10 and Q11
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GLP QMSR Master Handbook
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EU Medical Device Regulation 2017-745
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21 CFR Parts 11, 203, 205 - PDMA
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21 CFR Parts 112 and 117 - ENGLISH/SPANISH
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Canadian GMP Guidelines GUI-0001 July 1, 2020
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EU cGMPs for ATMP - 2018 Advanced Therapy Medicinal Products
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EU GMPs with Annex 1 Sterile Medicinal Products
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EU GMPs with Annex 14 Human Blood or Plasma Products
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