Method Evaluation

CLSI Method Navigator Webinar

Inside CLSI: Turn Regulatory Complexity into a Clear Roadmap with CLSI Method Navigator

Join us for an introduction to the newly enhanced Method Navigator, an interactive framework that helps test developers and implementation laboratories identify, interpret, and address common requirements across the test life phases. Available as a free member benefit, with enhanced experience through eCLIPSE, Method Navigator supports test development from design through validation by integrating key regulatory references, downloadable checklists, and relevant CLSI guidance into a single resource.

Following a platform demonstration, this webinar will guide participants through three real-world case studies that illustrate how Method Navigator provides a clear, actionable roadmap for navigating the test life cycle more efficiently. Attendees will learn how Method Navigator can be used to identify applicable performance studies, document objective evidence, support validation and verification activities, maintain inspection readiness, and track requirements throughout the life of a test method. 

Featured case studies focus on:

  • Laboratory-developed tests.
  • Medical device manufacturers develop a novel test method.
  • End-user medical laboratories verifying a new commercially available assay.

The webinar will conclude with a discussion featuring industry, laboratory, and CLSI experts who will share practical implementation insights and answer audience questions.

This webinar is ideal for professionals involved in test development, validation, regulatory readiness, and test implementation, including:  

  • IVD manufacturers
  • Medical laboratory LDT developers
  • End user implementation laboratories
  • Regulatory and quality professionals
  • Validation and verification teams 

Date: 30 September 2026 | 1:00 PM - 2:00 PM EDT 

September 30, 2026

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Scope

Learn how Method Navigator brings the CLSI Quality Management System, CLSI Test Life Phases Model, and regulatory, accreditation, and international standards into one streamlined product.  

​Learning Objectives

  • Identify the requirement, objective evidence, and how to access supportive content provided for each phase of CLSI’s Test Life Phases Model.  
  • Apply Method Navigator guidance to both laboratory-developed and commercial test methods.
  • Review the tracking tools and linked CLSI references that support audit and inspection readiness. 
Speakers
Marvin Berman, PhD, Abbott Laboratories
Paula Ladwig, MS, MLS(ASCP), Mayo Clinic
Tabitha Kern, MS, MLS (ASCP)CM, CLSI 
Supporting Resources
CLSI MNav
Method Navigator
Subscription
Method Evaluation
Free
Scope

Learn how Method Navigator brings the CLSI Quality Management System, CLSI Test Life Phases Model, and regulatory, accreditation, and international standards into one streamlined product.  

​Learning Objectives

  • Identify the requirement, objective evidence, and how to access supportive content provided for each phase of CLSI’s Test Life Phases Model.  
  • Apply Method Navigator guidance to both laboratory-developed and commercial test methods.
  • Review the tracking tools and linked CLSI references that support audit and inspection readiness. 
Speakers
Marvin Berman, PhD, Abbott Laboratories
Paula Ladwig, MS, MLS(ASCP), Mayo Clinic
Tabitha Kern, MS, MLS (ASCP)CM, CLSI 
Supporting Resources
CLSI MNav
Method Navigator
Subscription
Method Evaluation
Free