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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 BodyPartTopic
US FDA11Electronic Records; Electronic Signatures
US FDA58Good Laboratory Practice for Nonclinical Laboratory Studies
US FDA210cGMP in Manufacturing, Processing, Packing, Or Holding of Drugs; General
US FDA211cGMP for Finished Pharmaceuticals
US FDA600Biological Products; General
US FDA601Licensing, Biologics
US FDA610General Biological Products Standards
US FDA820Quality System Regulations
US FDA50Protection of Human Subjects
US FDA54Financial Disclosure by Clinical Investigators
US FDA56Institutional Review Boards
US FDA801Labeling
US FDA803Medical Device Reporting
US FDA806Medical Devices; Reports of Corrections and Removals
US FDA807Establishment Registration and Device Listing for Manuf. and Initial Importers
US FDA809In-Vitro Diagnostic Products for Human Use
US FDA810Medical Device Recall Authority
US FDA812Investigational Device Exemptions
US FDA814Premarket Approval of Medical Devices
US FDA821Medical Device Tracking Requirements
US FDA822Postmarket Surveillance
US FDAMedical Device Quality System Manual
US FDAQuality Systems Approach to Pharmaceutical cGMP Regulations
US FDAPMA & 510k Guidance Document
ICHQ2Analytical Validation
ICHQ4-4B Annex 12Pharmacopoeias
ICHQ5A-5EQuality of Biotechnological Products
ICHQ7Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ICHQ8Pharmaceutical Development
ICHQ9Quality Risk Management
ICHQ10Pharmaceutical Quality System