LEVERAGING KNOWLEDGE - DRIVING PERFORMANCE - DESIGNING THE FUTURE

Clinical Forum Teams work extensively with industry, healthcare organisations, academia regulators to link stakeholders and to facilitate the development of the environment for electronic clinical research. We have conducted surveys, developed tools, built an extensive base of knowledge of information relevant to the successful implementation of eClinical solutions.

Join the eClinical Forum to participate in cross-industry initiatives and to benefit from early access to pre-competitive information on best practices and trends.

ECF Teams and Projects

Event date: 10/11/2026 10:00 - 11:00 Export event
Jana Summa
/ Categories: Webinar/Telecon, Visible by Public

eCF Webinar November: FDA warning letters for audit trail analytics

Webinar November 2026

eCF Webinar November 2026: FDA warning letters are telling you what to fix. Is your audit trail analytics listening? 

FDA warning letters name what went wrong. They rarely explain what a functioning audit trail analytics program should have caught instead.
This session works through a FDA warning letter in detail and uses it as a case study, tracing the inspection finding back through the data to identify where the analytical signal existed, why it was missed, and what a fit-for-purpose audit trail review program would have detected before the letter was written.

The goal is not to teach you about the letter, but to give you a method for reading any letter as a diagnostic for your own program. Attendees leave with a structured approach for connecting FDA inspection findings to audit trail analytics design, and a clearer picture of where their current programs may have the same blind spots.

The webinar will be held on Tuesday, November 10, 2026 and will take place twice. 

You can find more information and sign up here

Print
143 Rate this article:
No rating