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GAMP® 5 Second Edition: An Overview - Critical Thinking for Smarter Validation | GAMP 5 Second Edition provides more than just an update on good practice and facilitating innovative new technologies. It also promotes critical thinking to make validation practices ever more cost effective and efficient. In this presentation learn about the importance of context (seeing the role of the computer system within the broader business process being supported), making better use of supplier activities to reduce duplicated validation effort, and leveraging automated tools alongside the application of science-based risk management. The latest FDA guidance on computer software assurance is also discussed. It all adds up to smarter validation.
Speaker(s):
Dr. Guy
Wingate,
PhD,
Independent Consultant,
Glaxosmithkline PLC (Retired)
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