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GAMP Microlearning: Infrastructure

GAMP® Microlearning: Infrastructure

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on Infrastructure & Qualification. The "Infrastructure & Qualification" section of the GAMP® Basic Principles (T45) training course explores the foundational role of IT infrastructure in supporting GxP computerized systems and ensuring compliance with regulatory expectations. Participants learn the distinction between validation (for applications) and qualification (for infrastructure), and how to apply a lifecycle approach to infrastructure components. The module covers key concepts such as standardized platform builds, scalable qualification strategies, and leveraging automation for efficiency and reliability. It emphasizes the importance of documented good IT practices, the role of IT Quality (ITQ) functions, and the use of tools like ITIL for infrastructure management. Learners also examine the regulatory expectations for infrastructure oversight, including the role of the Quality Unit, and how to ensure traceability, control, and fitness for purpose across diverse infrastructure environments.
165.00