Microlearning: GAMP® Basic Principles – Legacy Systems
Overview
The "Legacy Systems" section of the GAMP® Basic Principles (T45) training course addresses the challenges and regulatory expectations surrounding operational GxP systems that lack sufficient validation or documentation. Participants learn how legacy systems arise from organizational changes to neglected validation and documentation, and why they pose compliance risks. Drawing guidance from PIC/S and EU Annex 11, the module emphasizes the need to demonstrate fitness for intended use, manage GxP risks, and maintain system control. Learners explore how to apply GAMP® 5 lifecycle principles retrospectively, using historical data, targeted documentation updates, and risk-based validation strategies. The course outlines practical steps for achieving and then maintaining compliance through system inventories, periodic review, change control, and specification management. Exercises reinforce how to assess legacy systems and develop validation plans tailored to their current use and risk profile.
- 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 |
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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