CLSI LDT Webinar
LDT Foundations Webinar Series: Exploring Standards that Support LDT Developers
Wednesday, 30 October 2024 | 1:00-2:00 PM ET
Agenda:
• Introduction and Updates to the FDA's Final Rule on LDTs
• Guidance for Stage 1
• Overview of QMS11 and QMS18
• Q&A Discussion
Learning Objectives
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Describe three steps you can take to prepare for stage 1 of the FDA's Final Rule on Laboratory Developed Tests (LDTs).
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Identify two resources that your laboratory can use to prepare for stage 1.
Speakers:
Shannon Bennett, MS, MBA, CMQOE(ASQ)
Christopher Dailey, PhD
Lucia Berte, MA, MT(ASCP)SBB,DLM,CQA(ASQ)CMQ/OE
Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM
Earn 1.0 P.A.C.E.® credits for this session. Register for this session and you will be automatically pre-registered for the full LDT series!
Member price:
List Price:Details
Chairholder: Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM; Shannon Bennett, MS, MBA, CMQOE(ASQ)
Date of Webinar: October 30, 2024
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.