Method Evaluation

CLSI LDT Design Controls Webinar

LDT Foundations Webinar Series: Navigating Design Controls for LDTs

Watch the third webinar on-demand in CLSI's series on FDA’s Final Rule on Laboratory Developed Tests (LDTs). This session focused on navigating design controls, providing laboratories with practical strategies and resources to implement these requirements effectively. Experts discussed key principles, highlighted useful tools, and answered questions in a panel discussion

Agenda:

  • Introduction
  • Design Control Fundamentals for LDTs
  • Panel Discussion
February 04, 2025
1.00

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Free

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Scope

Learning Objectives

  • Describe three steps to prepare for establishing design controls.
  • Identify two resources your laboratory can use for implementation.

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
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
Supporting Resources
CLSI EPLDTQG
Validating Performance Claims for Laboratory-Developed Tests
Companion
Method Evaluation
Free
Scope

Learning Objectives

  • Describe three steps to prepare for establishing design controls.
  • Identify two resources your laboratory can use for implementation.

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
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
Supporting Resources
CLSI EPLDTQG
Validating Performance Claims for Laboratory-Developed Tests
Companion
Method Evaluation
Free