AI in Operations (AIO) Working Group
Advancing the application of artificial intelligence across GxP operations (including manufacturing, quality, supply chain, and related functions) to enable predictive product quality and operational excellence. Current initiatives focus on AI-enabled Annual Product Quality Reviews (APQRs) as a foundation for continuous, risk-based process verification capable of identifying emerging quality signals before they become product issues.
Working Group Leaders
Contributors:
Lacey Harbour, Pathway for Patient Health
Kent Joshi, AgiLaunchIT
Filsun Moussa, Medtronic
Matthew Oremland, Tidal Wave Analytics
Mike Salem, Gilead Sciences
Alison Sathe, Redica Systems
Mario Stassen. Stassen Pharmaconsult
Publications:
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