Microbiology

CLSI AST Breakpoints Webinar

Updating Breakpoints—Challenges and Solutions for Various Stakeholders Webinar

Organized by the CLSI Outreach Working Group, this on-demand webinar discusses the challenges and solutions for AST testing faced by various stakeholders. It includes a panel discussion with participation by FDA.

June 25, 2022

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Scope

Learning Objectives

  • Discuss updating breakpoints in the clinical laboratory. 
  • Describe the Susceptibility Testing Manufacturers Association's (STMA) perspective on reviewing breakpoints. 
  • Review the Center for Drug Evaluation and Research (CDER) view on breakpoints. 
  • Recognize the Center for Devices and Radiological Health (CDRH) process for updating breakpoints. 
Speakers
Moderators
Janet Hindler, MCLS MT(ASCP), Microbiologist, Los Angeles County Department of Health
Jean B. Patel, PhD, D(ABMM), Principal Scientist, Microbiology, Beckman Coulter
Speakers
Romney M. Humphries, PhD, D(ABMM), Medical Director, Clinical Microbiology, Vanderbilt University Medical Center
Jean B. Patel, PhD, D(ABMM), Principal Scientist, Microbiology, Beckman Coulter
Dimitri Iarikov, MD, PhD, Center for Drug Evaluation and Research (CDER) US Food and Drug Administration
Natasha Griffin, PhD, Center for Devices and Radiological Health (CDRH) US Food and Drug Administration
Scope

Learning Objectives

  • Discuss updating breakpoints in the clinical laboratory. 
  • Describe the Susceptibility Testing Manufacturers Association's (STMA) perspective on reviewing breakpoints. 
  • Review the Center for Drug Evaluation and Research (CDER) view on breakpoints. 
  • Recognize the Center for Devices and Radiological Health (CDRH) process for updating breakpoints. 
Speakers
Moderators
Janet Hindler, MCLS MT(ASCP), Microbiologist, Los Angeles County Department of Health
Jean B. Patel, PhD, D(ABMM), Principal Scientist, Microbiology, Beckman Coulter
Speakers
Romney M. Humphries, PhD, D(ABMM), Medical Director, Clinical Microbiology, Vanderbilt University Medical Center
Jean B. Patel, PhD, D(ABMM), Principal Scientist, Microbiology, Beckman Coulter
Dimitri Iarikov, MD, PhD, Center for Drug Evaluation and Research (CDER) US Food and Drug Administration
Natasha Griffin, PhD, Center for Devices and Radiological Health (CDRH) US Food and Drug Administration