NAVIGATION
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 |
