Microlearning: GAMP® Basic Principles – Operational Phase for GxP Regulated Systems

Overview

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 to tailor operational activities to 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.

• 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

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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