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GAMP Microlearning: Effective and Efficient Compliance

GAMP® Microlearning: Effective and Efficient Compliance

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on Effective and Efficient Compliance. The "Effective and Efficient Compliance" section of the GAMP® Basic Principles (T45) training course emphasizes strategies for achieving regulatory compliance in a streamlined, risk-based, and resource-conscious manner. Participants explore key efficiency improvements such as leveraging supplier documentation, combining specification deliverables, using automated testing tools, and minimizing unnecessary documentation. The module highlights how risk-based decision-making applies across the system lifecycle—from specification and testing to operational change management and system retirement. Learners gain insights into optimizing testing practices, managing test evidence, and applying critical thinking to reduce overhead while maintaining quality. The course equips professionals to implement compliance practices that are both rigorous and efficient, aligning with GAMP® 5 principles and modern regulatory expectations.
165.00