Method Evaluation

CLSI LDT Design Controls Webinar

LDT Foundations Webinar Series: Navigating Design Controls for LDTs

This webinar is the third offering in CLSI's series designed specifically for Laboratory Developed Tests (LDTs).  Designed originally to help LDTs prepare for new regulation coming from the FDA, this webinar provides timeless guidance and practical strategies for navigating design controls and successfully implementing requirements in all regulatory environments.

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