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LDT Foundations Webinar Series: Navigating Design Controls for LDTs

CLSI LDT Webinar

LDT Foundations Webinar Series: Navigating Design Controls for LDTs

Date: 4 February 2025 1:00 PM ET to 2:00 PM ET

Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). 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 around design controls, a highlight of useful resources, and a Q&A discussion.

Agenda: 

  • Introduction
  • Design Control Fundamentals for LDTs
  • Q&A Discussion

Speakers: 
Travis Schlappi, PhD, Assistant Teaching Professor at Arizona State University
Michelle Campbell MS, MLS(ASCP)MB,SC, Senior Developer at Mayo Clinic and Assistant Professor at UNC School of Medicine
Shannon Bennett, MS, MBA, CMQOE(ASQ), Director of Regulatory Affairs at Mayo Clinic

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 implementing design controls. 

Earn 1.0 P.A.C.E.® credits for each session. Register for this session and you will be automatically pre-registered for the full LDT series!

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Details

Chairholder: Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM; Shannon Bennett, MS, MBA, CMQOE(ASQ)

Date of Webinar: February 4, 2025

CLSI LDT Webinar Additional Details

This webinar series is dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Receive access to the entire series that will provide practical guidance, resources, and vital information for laboratories. CLSI will update this series frequently with new webinar dates, topics, and other LDT resources. 

LDT Series

Webinar 1 | An Overview of FDA's Final Rule on LDTs
Webinar 2 | Exploring Standards that Support LDT Developers in Stage 1
Webinar 3 | Design Controls | Winter 2025
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. 

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