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GAMP Microlearning: Quality Risk Management (QRM)

GAMP® Microlearning: Quality Risk Management (QRM)

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on QRM. The "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 tools that evaluate severity, probability, and detectability. The course introduces practical strategies for managing risk at both the system and functional levels, including the use of appropriate controls, verification activities, and periodic reviews. Learners also explore how to tailor the rigor of assessments based on complexity, uncertainty, and importance, and how to apply QRM principles to various system categories and lifecycle stages.
165.00