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.
Date: Tuesday, November 10, 2026 Duration: One hour
Time: 10am CET/ 4am EST and 4pm CET/10am EST. If you cannot join, please register to receive the recording the next day.
Speaker: Nechama Katan, founder of Wicked Problem Wizards and a recognized practitioner at the intersection of Risk-Based Quality Management, audit trail analytics, and AI readiness in clinical trials.
Webinar 1:
Webinar 2:
Recording: A link to the recording will be provided the next day, to those who have registered for this.
Open To: This webinar will be available to staff from eClinical Forum member companies. Please register with your company mail. For information on eCF membership, please see www.eclinicalforum.org/membership or send an inquiry to info@eclinicalforum.org.
Background: eClinical Forum webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The eClinical Forum does not endorse any particular technology, system or platform. For more information, please reply to webinars@eclinicalforum.org