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Good Clinical Practice – Medical Device
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FDA DEA GMP Master Reference Guide
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21 CFR 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products
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21 CFR 11, 101, 110, 117, 120, 123 - GMPs for Fish Industry with Food Labeling
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US FDA, Canadian and European MDR
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Medical Device Quality Systems Manual with 11, 210/211, 820 and QMSR Audit Checklist
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ICH Q7, ICH Q8(R2), ICH Q9(R1), ICH Q10 and ICH Q12 Combination
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21 CFR Part 213 - Current Good Manufacturing Practice for Medical Gases
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US, EU and Canadian Medical Device Combination
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GCLP Good Clinical Laboratory Handbook - 4.5x7.5
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21 CFR Part 11, 58 GLP and OECD Series 1 GLP
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EU and US GMPs with Q7 API
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21 CFR 210/211 with Keyword Index
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21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs
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503B Compounding Master Guide
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21 CFR 801 - Labeling - Medical Device
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MHRA, EU & ICH GMP Handbook
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21 CFR Part 822 - Postmarket Surveillance
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GLP Analytical Stability Handbook - 4.5x7.5
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21 CFR 110, 117, 130, 131, 133 - Milk and Dairy
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21 CFR 11, 58, 210/211, 820 - Master GMP Trainer
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21 CFR 11, 58 - Electronic Records with Scope & App. and GLP
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21 CFR 11, 210/211 - Electronic Records with Drug GMPs
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8-Hour Monthly GMP Training, Certificate, GMP Handbook & e-Workbook
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QSIT -Quality System Inspection Technique
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21 CFR Part 4 Combination Products with 820
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21 CFR Parts 112 Produce and 117 Food GMPs
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EU GMPs with Annex 11, 15 - Computerized Systems and Validation
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21 CFR 803 - Medical Device Reporting
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21 CFR 4 - Regulation of Combination Products
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21 CFR 117 - GMPs for Human Food - ENGLISH/SPANISH
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21 CFR 11, 110, 112, 117, 120 - Produce cGMPs -
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21 CFR Part 830 Unique Device Identification
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Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14
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Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs
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Medical Device QSIT Manual with 11, 803, 806, 820 and 821
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