Microlearning: GAMP® Basic Principles – Regulations and Regulators
Overview
The "Regulations and Regulators" section of the GAMP® Basic Principles (T45) training course provides a comprehensive overview of the regulatory landscape governing computerized systems in the pharmaceutical industry. It explores key global initiatives and regulations, including the FDA’s 21st Century CGMPs and EU GMP Annex 11, and emphasizes the shift toward risk-based, science-based, and quality systems-based approaches. Participants gain insights into the regulatory hierarchy from laws and regulations to guidance documents and learn how to apply these frameworks to ensure compliance, data integrity, and product quality. The course highlights critical incidents, regulatory expectations, and enforcement actions to underscore the importance of robust validation, change control, and lifecycle management of computerized systems.
- Earn 0.13 CEUs
- This course is self-paced. (Courses usually take 15 to 90 minutes to complete.)
- This course is part of the GAMP® Basic Principles Bundle
Registration Fee
| Member | Nonmember |
|---|---|
| US$145 | US$165 |
Buy Now Return to Online Learning
For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses