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21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product Master
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21 CFR 4 - cGMP for Combination Products
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21 CFR 11 - Electronic Records with Scope & Application
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21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist
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21 CFR 11 - Electronic Records with Scope & Application and Preambles
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21 CFR 11 - with Scope & Appl. & Computerized Systems used in Clinical Investigations
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21 CFR 11, 101, 110, 117, 120, 123 - GMPs for Fish Industry with Food Labeling
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21 CFR 11, 110, 111 and 117 - Food and Supplement GMPs
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21 CFR 11, 110, 117, 120 - Food GMPs
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21 CFR 11, 110, 117, 120, 123 - GMPs for Fish Industry
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21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs
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21 CFR 11, 203, 205 - PDMA with Electronic Records
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21 CFR 11, 210/211 - Electronic Records with Drug GMPs
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21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH
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21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH
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21 CFR 11, 210/211 with Keyword Index
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21 CFR 11, 210/211, 606, 820 - Electronic Record, Drug, Blood & Device
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21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"
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21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
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21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs -ENGLISH/SPANISH
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21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH
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21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook
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21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
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21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook
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21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Master2
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21 CFR 11, 58 - Electronic Records with Scope & App. and GLP
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21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
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21 CFR 11, 58, 210/211, 820 - Master GMP Trainer
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21 CFR 11, 58, 210/211, 820, ICH E6(R2) - GMP 2 Combination
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21 CFR 11, 58, 820 - Electronic Records with GLP and QSR
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21 CFR 11, 606 - Electronic Systems with Blood Industry GMPs
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21 CFR 11, 820 - Electronic Records with Quality Systems Regulations
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21 CFR 11, 820 QSR and 830 UDI
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21 CFR 13 - Public Hearing
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21 CFR 50 - Protection of Human Subjects
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21 CFR 50, 54, 56 - GCP Drug Approval Handbook
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21 CFR 54 - Financial Disclosure by Clinical Investigators
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21 CFR 56 - Institutional Review Boards
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21 CFR 58 - Good Laboratory Practice
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21 CFR 58, 606 - Good Laboratory Practice for Blood Industry
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21 CFR 58, 820 - GLP and QSR
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21 CFR 101, 110 and 117 - Food Labeling Combination
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21 CFR 106, 107, 110 and 117 - Infant Formula Regulations
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21 CFR 108, 110, 113, 114 and 117 - GMPs for Low-Acid Foods
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21 CFR 110, 117, 130, 131, 133 - Milk and Dairy
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21 CFR 111 - Dietary Supplement handbook
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21 CFR 112 Produce for Human Consumption
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21 CFR Part 112 Produce and 117 Food GMPs
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21 CFR 115 and 118 Egg Products
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21 CFR 200 - General Drug
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21 CFR 200, 201 - General Drug & Drug Labeling Combination
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21 CFR 203 - Prescription Drug Marketing
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21 CFR 205 - Guidelines for Licensing of Wholesale Drug
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21 CFR 210/211 - Drug GMPs
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21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH
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21 CFR 210/211 - Drug GMPs-SPANISH
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21 CFR 210/211 with Drug Preambles
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21 CFR 210/211 with GMP Audit Check List
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21 CFR 210/211 with Keyword Index
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21 CFR 312 - Investigational New Drug Application
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21 CFR 312, 314, 511 - Human and Animal Drug Approval
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21 CFR 314 - Applications for FDA Approval to Market a New Drug
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21 CFR 316 - Orphan Drugs
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21 CFR 320 - Bioavailability and Bioequivalence Requirements
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21 CFR 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls
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21 CFR 600 - Biological Products: General
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21 CFR 600, 601, 610 - Biologic GMP
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21 CFR 601 - Licensing - Biologics
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21 CFR 606 - Blood Industry
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21 CFR 610 - General Biological Products Standards
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21 CFR 640 - Add. Standards for human blood and blood products
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21 CFR 660 - Add. Standards for Diagnostic Substances for Lab. Tests
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21 CFR 680 - Additional Standards for Miscellaneous Products
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21 CFR 801 - Labeling - Medical Device
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21 CFR 803 - Medical Device Reporting
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21 CFR 806 - Medical Devices; Reports of Corrections and Removal
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21 CFR 807 - Estab. Reg. and Device Listing for Manufacturers and Initial Importers of Devices
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21 CFR 809 - In-Vitro Diagnostic Products
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21 CFR 810 - Medical Device Recall Authority
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21 CFR 812 - Investigational Device Exemptions
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21 CFR 814 - Premarket Approval of Medical Device
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21 CFR 820 - Quality System Regulations
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21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH
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21 CFR 820 - Quality System Regulations-SPANISH
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21 CFR 820 with Medical Device QSIT Manual
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21 CFR Part 117 - Food GMPs
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21 CFR 1270 - Human Tissue Intended for Transplantation
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21 CFR 1271 - Human Cells, Tissues, Cellular and Tissue…
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21 CFR 1270, 1271 - Cell Tissue
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503B Compounding and Packaging
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510k and PMA Guidelines
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Canadian GMP Guidelines GUI-0001 2018
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Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA
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Clinical Master Reference Guide
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Dietary Supplement Master Handbook
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Electronic Systems Master Handbook 1
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EU and US GMPs with Annex 1
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EU and US GMPs with Annexes 11 and 15
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EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10
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EU and US GMPs with Q7 API
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EU GMPs with Annex 1 Sterile Medicinal Products
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EU GMPs with Annex 10 Inhalation Products
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EU GMPs with Annex 11 Computerized Systems
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EU GMPs with Annex 11, 15 - Computerized Systems and Validation
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EU GMPs with Annex 11, 15, 16 and ICH Q7
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EU GMPs with Annex 11, 15, 16, 18, 19
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EU GMPs with Annex 12 Ionizing Radiation
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EU GMPs with Annex 13 Investigational medicinal Products
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EU GMPs with Annex 14 Human Blood or Plasma Products
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EU GMPs with Annex 15 Qualification and Validation
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EU GMPs with Annex 16 Qualified Person and Batch Release
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EU GMPs with Annex 17 Parametric Release
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EU GMPs with Annex 19 Reference and Retention Samples
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EU GMPs with Annex 2 Biological
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EU GMPs with Annex 3 RadioPharma
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EU GMPs with Annex 4 Vet. products other than Immuno
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EU GMPs with Annex 5 Immunolgical Vet. Products
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EU GMPs with Annex 6 Manufacture of Medicinal Gases
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EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
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EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
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EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
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EU GMPs with ICH Q7, Q8(R2), Q9 and Q10
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Eudralex - Pharmacovigilance for Medical Products Volume 9a
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FDA DEA GMP Master Reference Guide
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GMP International Master Reference Guide
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GMP Medical Device Master Reference Guide
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ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
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ICH E4 - Dose-Response Information to Support Drug Registration
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ICH E6(R2) - Good Clinical Practice
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ICH E8 - General Considerations for Clinical Trials
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ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials
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ICH Q10 - Pharmaceutical Quality System
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ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
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ICH Q1E - Evaluation of Stability Data
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ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology
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ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes
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ICH Q7 with Q7 Auditors Check List
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ICH Q7, Q8(R2), Q9 and Q10 Combination
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ICH Q7, Q8(R2), Q9 and Q10 with FAQ
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ICH Q7, Q8, Q9, Q10 and Q11
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ICH Q8(R2) - Pharmaceutical Development
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ICH Q9 - Quality Risk Management
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ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
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ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
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ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
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In Vitro Diagnostics 98/79/EC Medical Devices
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In Vitro Diagnostics Master Handbook
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Japanese GMP for Drugs and Quasi-drugs - 2005
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Medical Device Clinical with EU Directive
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Medical Device Combination 2
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Medical Device QSIT Manual with 11 and 820
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Medical Device QSIT Manual with 11, 803, 806, 820 and 821
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Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist
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Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
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Medical Device Quality Systems Manual with 820 and QSR Audit Checklist
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Title 21 CFR Parts 1 - End Nine Volume Set
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US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10
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US, EU and Canadian Medical Device Combination
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US, EU and Japanese GMPs
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Canadian - SOR98-282 Medical Devices Regulations
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FDA Guidance Documents
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Importing Directions: -Food
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FDA Meetings - Upcoming
h2
Regulatory Affairs ORA
h2
Food - Nutrition Industry
h2
Vitamins Weight Control
h2
21 CFR 210/211 - Drug GMPs - Add Parts 11 Electronic Systems and 820 QSR for Device
h2
21 CFR 820 - Quality System Regulations - Include Audit Checklist with ISO 13485 References
h2
21 CFR 112 Produce for Human Consumption also in a combination English / Spanish
h2
21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
h2
21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
h2
21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook
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GMP International Pharma. Master Reference Guide - 900+ pages of Guidance and Regulations
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GMP Medical Device Master Reference Guide - Over 900 pages including EU Directive 2017/745
h2
Dietary Supplement Master Handbook - Includes Guides and Regulations for Supplements
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21 CFR Part 117 - GMPs Hazard Analysis, and Risk-Based Preventive Controls for Food
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In Vitro Diagnostics Master Handbook - Over 500 Pages including EU Directive 2017/746
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