Method Evaluation

CLSI LDT Overview Webinar

LDT Foundations: An Overview of FDA's Final Rule on LDTs

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:

  • Understanding the FDA's Final Rule: Key takeaways and implications
  • Method Navigator as an LDT Resource: Tools to streamline compliance
  • Panel Discussion: Get your questions answered by industry experts
August 15, 2024
1.00

{{FormatPrice(currentPrice)}}

Free

{{FormatPrice(nonMemberPrice)}} List Price
This is your member pricing.
Notify Me About New Editions
Scope

Learning Objectives:

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

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

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

Speakers
Shannon Bennett, MS, MBA, CMQOE(ASQ)
Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM
Jonathan Genzen, MD, PhD, MBA
Tabitha Kern, MS, MLS(ASCP)CM
Supporting Resources
CLSI EPLDTQG
Validating Performance Claims for Laboratory-Developed Tests
Companion
Method Evaluation
Free
Scope

Learning Objectives:

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

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

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

Speakers
Shannon Bennett, MS, MBA, CMQOE(ASQ)
Michelle Campbell MS, MLS(ASCP)CMMBCM, SCCM
Jonathan Genzen, MD, PhD, MBA
Tabitha Kern, MS, MLS(ASCP)CM
Supporting Resources
CLSI EPLDTQG
Validating Performance Claims for Laboratory-Developed Tests
Companion
Method Evaluation
Free