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Regulatory Reference Handbooks

The Good Manufacturing Practices contained within Title 21 of the Code of Federal Regulations ensure well-engineered, current systems that lead to predictable, high quality products.  Help your employees comply with these requirements by providing them with the appropriate regulations and guideline handbooks.

Applicable handbooks are available with the purchase of any training program.

Contact us today to schedule your training:
Toll Free – 866.872.2070

Email[email protected]

 Available handbooks:

Issuing Body Part Topic
US FDA 11 Electronic Records; Electronic Signatures
US FDA 58 Good Laboratory Practice for Nonclinical Laboratory Studies
US FDA 210 cGMP in Manufacturing, Processing, Packing, Or Holding of Drugs; General
US FDA 211 cGMP for Finished Pharmaceuticals
US FDA 600 Biological Products; General
US FDA 601 Licensing, Biologics
US FDA 610 General Biological Products Standards
US FDA 820 Quality System Regulations
US FDA 50 Protection of Human Subjects
US FDA 54 Financial Disclosure by Clinical Investigators
US FDA 56 Institutional Review Boards
US FDA 801 Labeling
US FDA 803 Medical Device Reporting
US FDA 806 Medical Devices; Reports of Corrections and Removals
US FDA 807 Establishment Registration and Device Listing for Manuf. and Initial Importers
US FDA 809 In-Vitro Diagnostic Products for Human Use
US FDA 810 Medical Device Recall Authority
US FDA 812 Investigational Device Exemptions
US FDA 814 Premarket Approval of Medical Devices
US FDA 821 Medical Device Tracking Requirements
US FDA 822 Postmarket Surveillance
US FDA Medical Device Quality System Manual
US FDA Quality Systems Approach to Pharmaceutical cGMP Regulations
US FDA PMA & 510k Guidance Document
ICH Q1A-1F Stability
ICH Q2 Analytical Validation
ICH Q3A-3C Impurities
ICH Q4-4B Annex 12 Pharmacopoeias
ICH Q5A-5E Quality of Biotechnological Products
ICH Q6A-6B Specifications
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICH Q8 Pharmaceutical Development
ICH Q9 Quality Risk Management
ICH Q10 Pharmaceutical Quality System