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  21 CFR Part 11

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Most Popular Handbooks
 
Complete Listing of Handbooks!
21 CFR 106, 107, 110 - Infant Formula Regulations
21 CFR 108, 110, 113, 114 - GMPs for Low-Acid Foods
21 CFR 11 - Electronic Records with Scope & Application
21 CFR 11 - with Computerized Systems used in Clinical Investigations
21 CFR 11 - Electronic Records with Scope & Application and Part 11 Checklist
21 CFR 11 - Electronic Records with Scope & Application and Preambles
21 CFR 11, 110 - Electronic Records with Food GMPs
21 CFR 11, 110, 111 - Food and Supplement GMPs
21 CFR 11, 110, 120, 123 - GMPs for Fish Industry
21 CFR 11, 111 - Electronic Records with Dietary Supplement GMPs
21 CFR 11, 203, 205 - PDMA with Electronic Records
21 CFR 11, 210/211 - Electronic Records with Drug GMPs
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-ENGLISH/SPANISH
21 CFR 11, 210/211 - Electronic Records with Drug GMPs-SPANISH
21 CFR 11, 210/211 with Keyword Index
21 CFR 11, 210/211, 606, 820 - with Drug, Blood and Device QSR Industry GMPs
21 CFR 11, 210/211, 700/701 - Cosmetic with "Is It Soap or a Drug"
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs -ENGLISH/SPANISH
21 CFR 11, 210/211, 820 - Electronic Records with Drug and Device GMPs-SPANISH
21 CFR 11, 210/211, 820 with Audit Checklists - GMP Auditor’s Basic Handbook
21 CFR 11, 210/211, 820, ICH Q7 - Good Manufacturing Practice Handbook
21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R1) - Good Clinical Practice Handbook
21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination
21 CFR 11, 58 - Electronic Records with Scope & App. and GLP
21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs
21 CFR 11, 58, 210/211, 820 - Master GMP Trainer: Guidance Doc. GMPs for the 21st Century & Quality Syst. Approach to GMPs
21 CFR 11, 58, 210/211, 820, ICH E6(R1) - GMP 2 Combination Handbook
21 CFR 11, 58, 820 - Electronic Records with GLP and QSR
21 CFR 11, 606 - Electronic Systems with Blood Industry GMPs
21 CFR 11, 820 - Electronic Records with Quality Systems Regulations
21 CFR 110 - Food GMPs
21 CFR 110 - Food GMPs-ENGLISH/SPANISH
21 CFR 110 - Food GMPs-SPANISH
21 CFR 110, 111 - Food and Supplement GMPs
21 CFR 110, 130, 131, 133 - Milk and Dairy
21 CFR 111 - Dietary Supplement handbook
21 CFR 115 and 118 Egg Products
21 CFR 1270 - Human Tissue Intended for Transplantation
21 CFR 1270, 1271 - Cell Tissue
21 CFR 1271 - Human Cells, Tissues, Cellular and Tissue…
21 CFR 13 - Public Hearing
21 CFR 200 - General Drug
21 CFR 200, 201 - General Drug & Drug Labeling Combination
21 CFR 203 - Prescription Drug Marketing
21 CFR 205 - Guidelines for Licensing of Wholesale Drug
21 CFR 210/211 - Drug GMPs
21 CFR 210/211 - Drug GMPs-ENGLISH/SPANISH
21 CFR 210/211 - Drug GMPs-SPANISH
21 CFR 210/211 with Drug Preambles
21 CFR 210/211 with GMP Audit Check List
21 CFR 210/211 with Keyword Index
21 CFR 3 - Combination Product Basic Handbook - Definition, FAQ's & GMPs
21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
21 CFR 312 - Investigational New Drug Application
21 CFR 312, 314, 511 - Human and Animal Drug Approval
21 CFR 314 - Applications for FDA Approval to Market a New Drug
21 CFR 316 - Orphan Drugs
21 CFR 320 - Bioavailability and Bioequivalence Requirements
21 CFR 50 - Protection of Human Subjects
21 CFR 50, 54, 56 - GCP Drug Approval Handbook
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 58 - Good Laboratory Practice
21 CFR 58, 606 - Good Laboratory Practice for Blood Industry
21 CFR 58, 820 - GLP and QSR
21 CFR 600 - Biological Products: General
21 CFR 600, 601, 610 - Biologic GMP
21 CFR 601 - Licensing - Biologics
21 CFR 606 - Blood Industry
21 CFR 610 - General Biological Products Standards
21 CFR 640 - Add. Standards for human blood and blood products
21 CFR 660 - Add. Standards for Diagnostic Substances for Lab. Tests
21 CFR 680 - Additional Standards for Miscellaneous Products
21 CFR 801 - Labeling - Medical Device
21 CFR 803 - Medical Device Reporting
21 CFR 806 - Medical Devices; Reports of Corrections and Removal
21 CFR 807 - Establishment Registration and Device Listing
21 CFR 809 - In-Vitro Diagnostic Products
21 CFR 810 - Medical Device Recall Authority
21 CFR 812 - Investigational Device Exemptions
21 CFR 814 - Premarket Approval of Medical Device
21 CFR 820 - Quality System Regulations
21 CFR 820 - Quality System Regulations-ENGLISH/SPANISH
21 CFR 820 - Quality System Regulations-SPANISH
21 CFR 820 with Medical Device QSIT Manual
510k and PMA Guidelines
anadian GMP Guidelines 2009, Version 2 - Effective March 4, 2011
Chinese GMPs -SFDA - State Food & Drug Administration P.R. CHINA
Clinical Master Reference Guide
Dietary Supplement Master Handbook
Electronic Systems Master Handbook 1
EU and US GMPs with Annex 1
EU and US GMPs with Annexes 11 and 15
EU and US GMPs with ICH Q7, Q8(R2), Q9, Q10
EU and US GMPs with Q7 API
EU GMPs Chapter 1 - 9
EU GMPs with Annex 1 Sterile Medicinal Products
EU GMPs with Annex 10 Inhalation Products
EU GMPs with Annex 11 Computerized Systems
EU GMPs with Annex 11, 15 - Computerized Systems and Validation
EU GMPs with Annex 11, 15, 16 and ICH Q7
EU GMPs with Annex 11, 15, 16, 18, 19
EU GMPs with Annex 12 Ionizing Radiation
EU GMPs with Annex 13 Investigational medicinal Products
EU GMPs with Annex 14 Human Blood or Plasma Products
EU GMPs with Annex 15 Qualification and Validation
EU GMPs with Annex 16 Qualified Person and Batch Release
EU GMPs with Annex 17 Parametric Release
EU GMPs with Annex 19 Reference and Retention Samples
EU GMPs with Annex 2 Biological
EU GMPs with Annex 3 RadioPharma
EU GMPs with Annex 4 Vet. products other than Immuno
EU GMPs with Annex 5 Immunolgical Vet. Products
EU GMPs with Annex 6 Manufacture of Medicinal Gases
EU GMPs with Annex 7 Manufacture of Herbal Medicinal Products
EU GMPs with Annex 8 Sampling of Starting and Packaging Materials
EU GMPs with Annex 9 Manufacture of Liquids, Creams and Ointments
EU GMPs with ICH Q7
EU GMPs with ICH Q7, Q8(R2), Q9 and Q10
Eudralex - Pharmacovigilance for Medical Products Volume 9a
GLP Master Handbook
GMP - PAT Handbook
GMP International Master Reference Guide
ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
ICH E4 - Dose-Response Information to Support Drug Registration
ICH E6(R1) - Good Clinical Practice
ICH E8 - General Considerations for Clinical Trials
ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
ICH Q10 - Pharmaceutical Quality System
ICH Q1A(R2) - Stability Testing of New Drug Substances and Products
ICH Q1E - Evaluation of Stability Data
ICH Q2(R1) - Validation of Analytical Procedures: Text and Methodology
ICH Q5E - Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
ICH Q7 with Q7 Auditors Check List
ICH Q7, Q8(R2), Q9 and Q10 Combination
ICH Q7, Q8(R2), Q9 and Q10 with FAQ
ICH Q7, Q8, Q9, Q10 and Q11
ICH Q8(R2) - Pharmaceutical Development
ICH Q9 - Quality Risk Management
ICH S2(R1) - Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH S7A - Safety Pharmacology Studies for Human Pharmaceuticals
In Vitro Diagnostics 98/79/EC Medical Devices
In Vitro Diagnostics Master Handbook
Japanese GMP for Drugs and Quasi-drugs - 2005
Medical Device Clinical with EU Directive
Medical Device Combination 2
Medical Device QSIT Manual with 11 and 820
Medical Device QSIT Manual with 11, 803, 806, 820 and 821
Medical Device Quality Systems Manual with 11, 210/211, 820 and QSR Audit Checklist
Medical Device Quality Systems Manual with 820 and QSR Audit Checklist
US and Canadian GMPs with ICH Q7, Q8(R2), Q9, Q10
US, EU and Canadian Medical Device Combination
US, EU and Japanese GMPs
VICH GL9 Animal GCP
21 CFR Part 507 - cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Medical Device Quality Systems Manual with 11, 820, QSR Audit Checklist, 7382.845 with QSIT
11, 110, 117, 120 - Food GMPs
21 CFR Parts 11, 820 QSR and 830 UDI
21 CFR 4 - cGMP for Combination Products
Title 21 CFR Parts 1 - End Nine Volume Set
 

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