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GAMP Microlearning: User Software Activities

GAMP® Microlearning: User Software Activities

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on User Software Activities. The "Regulated Company and Supplier Activities" section of the GAMP® Basic Principles (T45) training course explores the collaborative roles and responsibilities of regulated companies and their suppliers throughout the computerized system lifecycle. Emphasizing a risk-based, scalable approach, the module outlines governance, system-specific tasks, and the importance of leveraging supplier involvement in areas such as requirements gathering, testing, training, and maintenance. Participants learn how to assess suppliers using various methods—from basic evaluations to on-site audits—and how to apply supplier good practices within a Quality Management System (QMS). The course also addresses cloud service provider management, including regulatory considerations, data integrity controls, and risk assessments tailored to service and deployment models. Learners gain clarity on accountability, shared responsibilities, and strategies for ensuring compliance in increasingly complex digital environments.
165.00