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GAMP Microlearning: Legacy Systems

GAMP® Microlearning: Legacy Systems

ISPE has created mirolearning offerings based upon the GAMP® Basic Principles (T45) training course.  This section focuses on Legacy Systems. 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 why they pose compliance risks. Drawing on 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 maintaining compliance, including system inventory, 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.
165.00