Microlearning: GAMP® Basic Principles – Infrastructure

Overview

The "Infrastructure" 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 good IT practice approach to infrastructure components. The module covers key concepts such as standardized platform builds, scalable qualification strategies, and automated approaches to improve efficiency and reliability. It emphasizes the importance of documented best IT practices, the role of IT Quality (ITQ) functions, the use of tools and automation, and the adoption of frameworks such as ITIL for infrastructure management. Learners also examine the regulatory expectations for infrastructure oversight, including the role of the Quality Unit, and how to ensure a state of control and fitness for purpose across diverse infrastructure environments.

• 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