LMK Webinars
TMF Talks Series: Document QC Beyond the Checklist
TMF Talks is a live, interactive webinar series built around real questions from the TMF community. Pooja Brahmbhatt and Ben Rogers will discuss what meaningful QC looks like in practice, including how to document findings, trends, and follow up actions. Attendees will gain insight into how strong QC practices strengthen accountability and provide credible evidence of oversight when teams are questioned during inspections.
TMF Talks Series: Practical TMF Indexing for Real-World Scenarios
Janice del Rosario and Ben Rogers will share practical examples and decision-making approaches that help teams create consistent, defensible indexing across studies. The discussion will emphasize how clear indexing supports retrieval, oversight, and the ability to confidently explain TMF structure during audits and inspections.
How to Demonstrate Effective Oversight in Your TMF Part 2
The discussion will cover how to select metrics that show quality and risk rather than volume, how to trend data to demonstrate continuous oversight, and how documentation and metadata work together to support a clear inspection narrative. Attendees will gain practical guidance on preparing evidence that inspectors can follow without additional explanation.
How to Demonstrate Effective Oversight in Your TMF Part 1
This session will explore how to define oversight responsibilities, align TMF practices with current regulatory expectations including ICH E6 R3, and avoid common gaps that weaken inspection narratives. Attendees will gain practical insight into building an oversight framework that supports quality decision-making and stands up to regulatory scrutiny.
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