Method Evaluation

CLSI LDT Stage 1 Webinar

LDT Foundations: Standards to Prepare for Stage 1 Requirements

Watch this on-demand panel discussion, designed to help your laboratory prepare for compliance with the FDA’s Final Rule on Laboratory Developed Tests (LDTs). This session breaks down the ruling’s impact and provides practical resources to guide your laboratory in adapting to the new requirements.

Agenda:

  • Detailed guidance for preparing for Stage 1
  • A review of CLSI standards that help laboratories prepare for Stage 1
  • Panel Discussion
October 30, 2024
1.00

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Scope

Learning Objectives 

  • Describe three steps you can take to prepare for stage 1 of the FDA's Final Rule on Laboratory Developed Tests (LDTs). 
  • Identify two resources that your laboratory can use to prepare for stage 1 of the ruling.

Basic: Entry level. No prior knowledge of subject necessary.

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

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)CM, MBCM, SCCM
Scope

Learning Objectives 

  • Describe three steps you can take to prepare for stage 1 of the FDA's Final Rule on Laboratory Developed Tests (LDTs). 
  • Identify two resources that your laboratory can use to prepare for stage 1 of the ruling.

Basic: Entry level. No prior knowledge of subject necessary.

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

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)CM, MBCM, SCCM