A Commentary on the Draft EMA Annex 15 Changes in the Context of The CAI OR Program
Why the EMA Annex 15 Concept Paper Signals a Shift—and How It Aligns with The CAI Six Pillars of Operational Readiness In Feb 2026 the EMA with...
Read MoreSustaining Reliability: Life Cycle Maintenance of AI Models in Drug Development (Part 2 of 3)
Nick Armstrong, Senior Director of Digital Enablement at CAI and co-chair of the ISPE Community of Practice on AI, specializes in the intersection of artificial...
Read MoreCAI Appoints Sheena Dempsey as Chief Executive Officer
Indianapolis (October 2, 2024)—CAI, a global professional services firm and trailblazer in operational readiness and excellence, today announced Sheena Dempsey as Chief Executive Officer (CEO)....
Read MoreLeveraging CAI Human Performance Services for the “People in Plant” Program: Driving Excellence in Pharmaceutical Manufacturing
The "People in Plant" (PiP) program is pivotal in recognizing and enhancing the contributions of employees in a pharmaceutical manufacturing facility. Implementing such a comprehensive...
Read MoreImplementing a Risk-based Approach to Calibration
How does your organization determine calibration test points, tolerances, and frequency? A simple rule of thumb to calibrate instruments at 10, 50, and 90% of...
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