WATCH THE FREE WEBINAR: Risk-Based CAPA Under ICH E6(R3)
Gillian Gittens and Jay Smith address the critical requirements for releasing AI features in a validated state that meets regulatory scrutiny. This session covers essential release mechanics including multi-environment promotion, documented risk-based testing, and ongoing monitoring strategies such as AppDex/latency targets and DR (disaster recovery) drills. Participants will learn how to align their AI implementations with recognized frameworks including HITRUST, SOC, ISO, and GAMP 5.
The focus is on ensuring AI implementations become sustainable operational advantages rather than one-off science projects. Attendees will gain practical knowledge about validation approaches, testing documentation requirements, and monitoring strategies that demonstrate continuous compliance. This episode is crucial for validation specialists, quality assurance professionals, and teams implementing AI in regulated environments.
Gillian Gittens
Senior Director, eClinical Strategy & Solutions
Jay Smith
Vice President, Product Management