WEBINAR SCHEDULE

Three and a half hours with industry quality leaders on the investigation, computerized system, and change control gaps that keep turning into inspection findings, and how to close them before an investigator finds them.

E6(R3) asks for risk proportionality and gives you no template for it. Central monitoring teams are using AI to detect site-level anomalies, surface patterns that suggest a protocol comprehension problem, and decide which visits need to happen at all. A signal only matters if someone acts on it, and the gap between a flag being raised and a monitor getting on a plane is exactly what an inspector will ask to see.

What emerging technologies and regulatory thinking signal for the year ahead

Techniques for improving documentation clarity and consistency across traditional, digital, and AI-supported validation approaches