LDT Foundations Webinar Series: Navigating Design Controls for LDTs

Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register now for all webinars 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 third webinar is a discussion around navigating design controls for FDA's Final Rule on LDTs, including resources for your laboratory to implement into practice. The webinar will include guidance for implementing design controls, a highlight of useful resources, and a Q&A discussion.

Webinar 3 | Tuesday February 4, 1:00 PM ET | Navigating Design Controls for LDTs

Introduction | Shannon Bennett, MS
Design Control Fundamentals for LDTs | 
Q&A Discussion | Moderated by Michelle Campbell MS, MLS(ASCP)MB,SC

Webinar 3 Learning Objectives 

1. Describe three steps you can take to prepare for establishing design controls.
2. Identify two resources that your laboratory can utilize for design controls. 

The second webinar is an overview and guide to of Stage 1 of FDA's Final Rule on LDTs, including resources for your laboratory to implement into practice. The webinar will include guidance for implementing stage 1, an overview of useful CLSI documents, and a Q&A discussion.

Webinar 2 | Wednesday, October 30, 1:00 PM ET | Standards to Prepare for Stage 1 Requirements

Introduction and Updates to the FDA's Final Rule on LDTs | Shannon Bennett, MS
Guidance for Stage 1 | Christopher Dailey, PhD
Overview of QMS11 and QMS18 | Lucia Berte  
Q&A Discussion | Moderated by Shannon Bennett, Featuring Michelle Campbell MS, MLS(ASCP)MB,SC

Webinar 2 Learning Objectives 

1. Describe three steps you can take to prepare for stage 1 of FDA's final rule regarding LDTs. 
2. Identify two resources that your laboratory can use to prepare for stage 1. 

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

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 | Webinar Agenda

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

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

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

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 3.0 P.A.C.E. credits for the first three webinars 

Upcoming Webinars

Webinar 4 | TBD, Spring 2025

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