LDT Foundations Webinar Series: Exploring Standards that Support LDT Developers

Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register for this first webinar and receive access to the entire series that will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, topics, and other LDT resources.

The first webinar is a panel discussion and overview of the FDA's Final Rule on LDTs, including practical resources for your laboratory to implement into practice. 

Webinar 1: FDA's Final Rule on LDTs | Thursday, August 15, 1:00 PM ET

Webinar Agenda

Overview of the Ruling | Shannon Bennett, MS, MBA, CMQOE(ASQ)

Q&A Discussion | Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM; Jonathan Genzen, MD, PhD, MBA; Shannon Bennett, MS, MBA, CMQOE(ASQ)

Method Navigator as a LDT Resource | Tabitha Kern, MS, MLS(ASCP)CM

Webinar 1 Learning Objectives 

1. Describe three main takeaways from the FDA's Final Rule on Laboratory Developed Tests (LDTs). 
2. Identify two resources that your laboratory can use to prepare for the ruling. 

Earn 1.0 P.A.C.E. credits for the first webinar. 

Upcoming Webinars

Webinar 2 | Guidance for Phase 1| TBD, Fall 2024

Webinar 3 | Design Controls | TBD, Winter 2025

CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.