Microlearning: GAMP® Basic Principles – Quality Risk Management (QRM)

Overview

TThe "Quality Risk Management (QRM)" section of the GAMP^® Basic Principles (T45) training course provides a structured, science-based approach to identifying, assessing, and controlling risks throughout the lifecycle of GxP computerized systems. Grounded in ICH Q9 R1 principles, the module emphasizes risk to patient safety, product quality, and data integrity, while also considering business impact. Participants learn to apply a five-step QRM process from initial system impact assessment to ongoing monitoring of controls using approaches that evaluate hazards for severity, probability, and detectability. The course introduces practical strategies for managing risk at the business process, system, and functional levels, primarily by the application of appropriate controls, supported by verification activities and periodic reviews. Learners also explore how to tailor the rigor, extent, and formality of assessments based on complexity, uncertainty, and importance, and how to apply QRM principles to various lifecycle stages.

• 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