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.
| 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
ISPE training is priced using Global Access Pricing, a model designed to reflect what a course actually costs in your country, not just what the US price converts to.
| Tier | Rate |
|---|---|
| Emerging Economy | $550 USD |
Global Access Pricing rates require an active ISPE membership.
