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GAMP Microlearning: Operational Phase

GAMP® Microlearning: Operational Phase for GxP Regulated Systems

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on the Operational Phase. The "Operational Phase for GxP Regulated Systems" section of the GAMP® Basic Principles (T45) training course focuses on the governance, control, and maintenance of computerized systems after deployment. Drawing from GAMP® 5 Second Edition, the module outlines key operational appendices covering areas such as system handover, support services, monitoring, incident management, change control, configuration management, backup and restore, business continuity, and system retirement. Participants learn how to tailor operational activities based on system risk and complexity, implement robust change and configuration management processes, and ensure data integrity through proper archiving and retrieval. The course emphasizes the importance of documented procedures, periodic reviews, and clear roles and responsibilities throughout the system’s lifecycle. Learners gain the tools to manage GxP systems effectively and compliantly in the operational phase.
165.00