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ISPE GAMP5 2nd edition changes & application
Join Stephen Ferrell, an ISPE GAMP5 second edition contributing author as he shares some of the key updates to ISPE's definitive guide to computer system validation and software assurance. Stephen covers key changes to the guidance in addition to his preliminary thoughts on the US FDA's draft computer software assurance guidance document.
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key takeaways
What you will learn
- GAMP5 has been updated for the first time in 13 years to provide contemporary guidance for the cloud, artificial intelligence/machine learning, and blockchain and critical thinking in the context of IT governance and software assurance
- A review of newly added appendices and contemporary updates to previous guidance
- An understanding of the applicability and definitions of computer software assurance period
Meet our speaker
Stephen Ferrell
Chief Product Officer, Valkit.aiStephen Ferrell is Chief Product Officer at Valkit.ai, a leading provider of validation and compliance solutions for the pharmaceutical industry. With over 25 years of experience in pharmaceutical quality systems and computerized system validation, Stephen has helped hundreds of companies navigate complex regulatory requirements while implementing innovative technology solutions. He was a contributing author to ISPE GAMP 5 2nd edition, as well as a number of other ISPE guides and industry publications.
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