Microlearning: GAMP® Basic Principles – User Supplier Activities

Overview

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 lifecycle of computerized systems. Emphasizing a risk-based, scalable approach, the module outlines governance, system-specific tasks, and the importance of leveraging supplier involvement in requirements gathering, testing, training, and maintenance. Participants learn how to assess suppliers using various methods from basic evaluations to on-site audits, and the fundamentals of 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.

• 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