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Products are filtered by different dates, depending on the combination of live and on-demand components that they contain, and on whether any live components are over or not.
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  • Contains 3 Component(s), Includes Credits Includes a Live Web Event on 12/05/2024 at 1:00 PM (EST)

    Join CLSI and CAP for a webinar discussing the clinical relevance of Staphylococcus species other than Staphylococcus aureus (SoSA).

    Thursday, 5 December 2024 | 1:00 – 2:30 PM ET

    Learning Objectives

    1. Discuss the clinical relevance of Staphylococcus species other than Staphylococcus aureus (SoSA).
    2. Describe issues surrounding detection of mecA-mediated beta-lactam resistance in SoSA.
    3. Explain situations for which species level identification of SoSA is suggested.

    Speakers

    Lars Westblade, PhD, Associate Director of our Clinical Microbiology Laboratory, Weill Cornell Medicine

    Jennifer Dien Bard, PhD, D(ABMM), F(CCM), Director of the Clinical Microbiology and Virology Laboratory, Children’s Hospital Los Angeles

    Earn 1.5 P.A.C.E.® credits for this webinar.

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

  • Contains 4 Component(s), Includes Credits Includes a Live Web Event on 11/12/2024 at 1:00 PM (EST)

    Participate in CLSI's webinar to gain knowledge on the latest method evaluation standards, get a sneak peek of EP47, and engage in a Q&A session addressing important topics in the industry.

    Participate in CLSI's webinar to gain knowledge on the latest method evaluation standards, get a sneak peek of EP47, and engage in a Q&A session addressing important topics in the industry.

    Tuesday, November 12, 2024, 1:00 PM ET
    Agenda
    Introduction | Tabby Kern, MS, MLS(ASCP)CM and Mark Kellogg, PhD, MT(ASCP), DABCC
    Framework of EP | Paula Ladwig, MS, MLS(ASCP)
    Overview of EP10: Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures| Michelle Campbell, MS, MLS(ASCP)CMMBCM, SCCM
    Preview of EP47: Evaluation of Reagent Carryover | Marvin Berman, PhD
    Q&A Discussion | Mark Kellogg, MT(ASCP), DABCC, Moderator

    Earn 1.0 P.A.C.E. Credits. 

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

  • Contains 7 Component(s), Includes Credits Includes a Live Web Event on 10/30/2024 at 1:00 PM (EDT)

    Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs) that will provide practical guidance, resources, and vital information for laboratories.

    Join CLSI for a webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register now for all webinars and receive access to the entire series that will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, topics, and other LDT resources.

    The second webinar is an overview and guide to of Stage 1 of FDA's Final Rule on LDTs, including resources for your laboratory to implement into practice. The webinar will include guidance for implementing stage 1, an overview of useful CLSI documents, and a Q&A discussion.

    Webinar 2 | Wednesday, October 30, 1:00 PM ET | Guidance for Stage 1 

    Introduction and Updates to the FDA's Final Rule on LDTs | Shannon Bennett, MS
    Guidance for Stage 1 | Christopher Dailey, PhD
    Overview of QMS11 and QMS18 | Lucia Berte  
    Q&A Discussion | Moderated by Shannon Bennett, Featuring Michelle Campbell MS, MLS(ASCP)MB,SC

    Webinar 2 Learning Objectives 

    1. Describe three steps you can take to prepare for stage 1 of FDA's final rule regarding LDTs. 
    2. Identify two resources that your laboratory can use to prepare for stage 1. 

    Webinar 1 | Thursday, August 15, 1:00 PM ET | An Overview of FDA's Final Rule on LDTs 

    The first webinar is a panel discussion and overview of the FDA's Final Rule on LDTs, including practical resources for your laboratory to implement into practice.

    Webinar 1 | Webinar Agenda

    Overview of the Ruling | Shannon Bennett, MS, MBA, CMQOE(ASQ)

    Q&A Discussion | Michelle Campbell MS, MLS(ASCP)MB, SC; Jonathan Genzen, MD, PhD, MBA; Shannon Bennett, MS, MBA, CMQOE(ASQ)

    Method Navigator as a LDT Resource | Tabitha Kern, MS, MLS(ASCP)


    Webinar 1 Learning Objectives 

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


    Earn 2.0 P.A.C.E. credits for the first two webinars. 

    Upcoming Webinars

    Webinar 3 | Design Controls | Winter 2025

    Webinar 4 | TBD, Spring 2025


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

  • Contains 9 Component(s), Includes Credits

    This session provides attendees with an understanding of how to use consensus standards as an indispensable tool for reducing the complexity of regulatory approval and clearance submissions.

    The appropriate use of consensus standards can greatly streamline FDA medical device submissions and reduce the burden for the conformity assessment elements. With appropriate use of FDA-recognized consensus standards, developers of devices and LDTs can submit declarations of conformity (DOC) to meet some premarket requirements and reduce the amount of supporting data and information that are submitted to FDA. This webinar will feature a live Q&A discussion.

    Speakers from each area will each present information on development and/or use of standards from their perspective:

    • Clinical and Laboratory Standards Institute (CLSI), for standards development process and standards available to industry.
    • FDA, for the appropriate use of standards.
    • Abbott, for the industry perspective on participation in standards development.

    Wednesday, August 28, 2024 | 1:00 PM ET

    Earn 1.0 P.A.C.E.®️ credits.

    Learning Objectives:

    1. Identify how the use of FDA-Recognized Standards can reduce the documentation burden of regulatory submissions.
    2. Determine how to use consensus standards effectively, including the submission of a Declaration of Conformity to the FDA.
    3. Summarize how participation in standards development is essential to ensuring that consensus standards incorporate regulatory needs. 

    Agenda
    Introduction and CLSI’s Standards Development Process, Barb Jones, PhD 

    FDA-Recognized Standards and Declaration of Conformity, Terry Woods, PhD 

    Participation in Standards Development, Vicki Petrides, MS 

    Q&A Discussion | All Panelists, Moderated by Barb Jones, PhD 


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

  • Contains 3 Component(s), Includes Credits

    Join CLSI for a webinar on how to build a cancer testing program and how to maintain and improve a cancer genomics laboratory. Our distinguished speakers will also discuss oncology test interpretation, clinical consultation, and new frontiers in testing.

    Join CLSI for a webinar on the newly published MM26 Cancer Molecular Testing: Principles of Oncology Test Interpretation, Laboratory and Assay Design, and Clinical Consultation. Learn how to build a cancer testing program and how to maintain and improve a cancer genomics laboratory. Our distinguished speakers will also discuss oncology test interpretation, clinical consultation, and new frontiers in testing. A live Q&A will be available for all of your questions about the CLSI MM26.

    Agenda

    • Oncology Test Interpretation and Clinical Consultation | Rong He, MD
    • Building and Growing a Cancer Testing Program | Sertac Kip, MD, PhD
    • Maintaining and Improving a Cancer Genomics Laboratory and New Frontiers in Testing | Dan Jones, MD, PhD
    • Q&A Discussion | Honey Reddi, PhD, Moderator 

    Earn 1.25 P.A.C.E.®️ credits. The on-demand recording for this webinar will be available on October 1.

    Learning Objectives

    • Appraise the knowledge base required of Molecular Oncology Laboratory Directors for optimal report interpretations and effective communication with clinical stakeholders (oncologists, genetic counselors, other providers).
    • Review the elements of building a successful and high-performing laboratory facility and testing and bioinformatics teams to support complex molecular oncology assays.
    • Identify best practices for sustainable lab quality and techniques to expand the reach and impact of your molecular oncology laboratory.

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

  • Contains 6 Component(s), Includes Credits

    This on-demand first webinar is a panel discussion and overview of the FDA's Final Rule on LDTs, including practical resources for your laboratory to implement into practice.

    The first on-demand webinar is a panel discussion and overview of the FDA's Final Rule on LDTs, including practical resources for your laboratory to implement into practice.

    Agenda

    Overview of the Ruling | Shannon Bennett, MS, MBA, CMQOE(ASQ)

    Q&A Discussion | Michelle Campbell MS, MLS(ASCP)MB, SC; Jonathan Genzen, MD, PhD, MBA; Shannon Bennett, MS, MBA, CMQOE(ASQ)

    Method Navigator as a LDT Resource | Tabitha Kern, MS, MLS(ASCP)

    Earn 1.0 P.A.C.E. credits for the first webinar.

    Learning Objectives 

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

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

  • Contains 8 Component(s), Includes Credits

    This annual webinar provides updates on the latest breakpoint recommendations from CLSI and offers practical strategies on incorporating those changes into clinical practice.

    This annual webinar is a collaboration between CLSI, Society of Infectious Disease Pharamcists (SIDP), and the American College of Clinical Pharmists (ACCP). It will provide updates on the latest breakpoint recommendations from CLSI from M100 | Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition, and offers practical strategies on incorporating those changes into clinical practice. Speakers will address the importance of partnerships between pharmacists and laboratory professionals on effective implementation of updates to enhance clinical practice. Audience polling will be included throughout, with an opportunity for Q&A at the end.

    CLSI members can register for free by signing into their CLSI account. Society of Infectious Disease Pharamcists SIDP and ACCP ID PRN members, please register on SIDP's website

    Live Date: Wednesday, August 7, 2024
    1:00 PM – 2:30 PM ET / 12:00 PM – 1:30 PM CT

    Earn 1.5 P.A.C.E.®️ credits. 

    Target Audience:
    This activity was planned to meet the educational needs of Pharmacists and Laboratory Professionals.

    Learning Objectives:

    ·       Summarize highlights from the M100—Performance Standards for Antimicrobial Susceptibility Testing, 34th Edition standards for antimicrobial susceptibility testing and reporting

    ·       Examine nuances that may be encountered when performing antimicrobial susceptibility testing (AST) for carbapenem-resistant bacteria.

    ·       Evaluate species-specific guidance for AST of Staphylococcus sp. and ceftriaxone dosing guidance for methicillin-susceptible Staphylococcus aureus

    ·       Discuss the revised breakpoints, reporting, and treatment recommendations for Stenotrophomonas maltophilia


    Clinical and Laboratory Standards Institute is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. Program.

    Virginia M. Pierce, MD, FIDSA

    Clinical Associate Professor of Pathology and Pediatrics (Pediatric Infectious Diseases)

    University of Michigan Medical School

    Dr. Pierce (faculty) has no financial relationships with an ineligible company to disclose.

    Navaneeth Narayanan, PharmD, MPH, BCIDP

    Clinical Associate Professor

    Rutgers University

    Dr. Narayanan (faculty): Research funding from Merck and Shionogi; Consultant, Advisor, Speaker

  • Contains 7 Component(s), Includes Credits

    Explore the challenges and successes of using beta-lactam combination agents from three different perspectives, including the pharmaceutical industry,​ the laboratory, and clinical practice.

    Please register for this course to claim P.A.C.E. credits from the June Education Session and access the on-demand recording. 

    Explore the challenges and successes of using beta-lactam combination agents from three different perspectives, including the pharmaceutical industry, the laboratory, and clinical practice. This session will delve into the development process of beta-lactam combination agents and laboratory requests and QC issues. The successes and failures of using beta-lactam combination agents in clinical practice will also be discussed.

    Learning Objectives

    • Describe the process in development of beta-lactam combination agents. 
    • Recognize requests that laboratories receive for testing these agents. 
    • Identify challenges laboratories face with QC issues when testing beta-lactam combination agents. 
    • Summarize the success and failures of using beta-lactam combination agents in clinical practice. 

    Clinical and Laboratory Standards Institute is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. Program.

    Romney Humphries, PhD D(ABMM)

    Professor, Department of Pathology, Microbiology and Immunology

    Vanderbilt University Medical Center

    Romney Humphries, PhD D(ABMM) is a Professor in the Department of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, where she is the Director of Infectious Diseases Laboratories and the Director of the Division of Laboratory Medicine. Romney received her PhD in bacteriology from the University of Calgary, Canada and a clinical and public health microbiology CPEP fellowship at UCLA.

    Dr. Humphries is passionate about clinical microbiology and antimicrobial resistance in particular. She is a champion for the development of novel diagnostic tests for infectious diseases to transform how patients with infections are managed.

    Greg Moeck, PhD

    Senior Vice President, Microbiology

    Venatorx Pharmaceuticals, Inc.

    Dr. Moeck is Senior Vice President, Microbiology at Venatorx Pharmaceuticals where he is responsible for ensuring comprehensive and timely characterization of investigational agents via clinical microbiology studies. He has spent over 15 years in antibacterial drug discovery and development, leading cross-functional teams or as a team member advancing the long-acting lipoglycopeptide oritavancin through nonclinical IND-enabling studies. Dr. Moeck has published over 50 papers in peer-reviewed journals, co-authored three book chapters, and is co-inventor on four patents relating to methods of treatment of bacterial infections.

    Andrew Fratoni, PharmD

    Associate Director, Clinical and Laboratory Studies

    Hartford Hospital

    Dr. Fratoni is the Associate Director of Clinical and Laboratory Studies at Hartford Hospital in Hartford, CT. 

  • Contains 7 Component(s), Includes Credits

    Join CLSI for a webinar on the latest in Antimicrobial Susceptibility Testing (AST) with the release of the 34th edition of the CLSI M100 document. Receive the latest guidance for implementing new breakpoints and standards into your laboratory practices.

    Join CLSI on April 17 at 1:00 ET for a webinar on the latest in Antimicrobial Susceptibility Testing (AST) with the release of the 34th edition of the CLSI M100 document. Receive the latest guidance for implementing new breakpoints and standards into your laboratory practices. Some of the major changes that will be discussed during the webinar include a significant reorganization of dosage recommendations, addition of sulbactam-durlobactam to breakpoints, a new Table 2A-2 for Salmonella and Shigella, and many more. A few substantive changes to the upcoming CLSI M02 and M07 will also be discussed.

    Learning Objectives:

    1. Identify the major changes found in the updated 34th edition of the CLSI M100 document.
    2. Design a strategy for implementing the new standard into laboratory practices.
    3. Develop a communication strategy for informing clinical staff of significant AST and reporting changes

    Register for the webinar to watch live on April 17, 2024 at 1 PM ET | 12 PM CT | 11 AM MT | 10 AM PT
    Or watch the webinar on-demand anytime. The on-demand recording will be available on April 19, 2024. 

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

    Janet Hindler, MCLS, MT(ASCP), F(AAM) (Moderator)

    Clinical Microbiologist

    Los Angeles County Department of Public Health

    Ms. Hindler has worked as a clinical microbiologist for over 5 decades, mostly at UCLA Health System, Los Angeles, CA and currently at the Los Angeles County Department of Public Health. She is a fellow in the American Academy of Microbiology and long-standing volunteer with the CLSI Subcommittee on Antimicrobial Susceptibility Testing (AST). She has authored or co-authored numerous publications and book chapters and has received many awards for her contributions to AST and clinical microbiology.

    April Bobenchik, PhD, D(ABMM)

    Medical Director Microbiology and Associate Professor

    Penn State Health and College of Medicine

    Dr. Bobenchik is a board-certified clinical microbiologist with over 20 years of experience working in the laboratory. She is currently the Medical Director of Microbiology and Virology at Penn State Hershey Medical Center and Associate Professor of Pathology at Penn State College of Medicine. She has been a volunteer with CLSI since 2013 and is the current co-chair of the text and table working group and a member of the outreach working group.

    Romney Humphries, PhD D(ABMM)

    Professor, Department of Pathology, Microbiology and Immunology

    Vanderbilt University Medical Center

    Romney Humphries, PhD D(ABMM) is a Professor in the Department of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center, where she is the Director of Infectious Diseases Laboratories and the Director of the Division of Laboratory Medicine. Romney received her PhD in bacteriology from the University of Calgary, Canada and a clinical and public health microbiology CPEP fellowship at UCLA.

    Dr. Humphries is passionate about clinical microbiology and antimicrobial resistance in particular. She is a champion for the development of novel diagnostic tests for infectious diseases to transform how patients with infections are managed.

  • Contains 4 Component(s), Includes Credits

    Este programa de LQMS, recientemente rediseñado y optimizado, presenta elementos atractivos e interactivos, además de instrucciones detalladas paso a paso que le ayudarán a navegar sin problemas los requisitos regulatorios y de acreditación.

    Este programa de LQMS, recientemente rediseñado y optimizado, presenta elementos atractivos e interactivos, además de instrucciones detalladas paso a paso que le ayudarán a navegar sin problemas los requisitos regulatorios y de acreditación. El programa incluye lecciones fáciles de navegar para cada uno de los 12 elementos esenciales del sistema de la calidad que aparecen en el modelo de sistema de gestión de la calidad (QMS) presentado en la directriz QMS01 del CLSI: un modelo de sistema de gestión de la calidad para servicios de laboratorio. Este paquete de descuento incluye el PDF del QMS01 del CLSI y acceso al programa de LQMS. Las características nuevas y dinámicas del curso incluyen:

    Comprobaciones de conocimiento regulares.

    • Gráficas interactivas.
    • Actividades divertidas de emparejamiento y clasificación.
    • Líneas de tiempo interactivas.
    • Interesantes lecciones en video.
    • Capacidad de búsqueda avanzada.

     Objetivos del programa:
    Al concluir el curso, usted podrá:

    1. Demostrar un conocimiento básico sobre los procesos que su laboratorio necesita para implementar y mantener un sistema de gestión de la calidad efectivo.
    2. Determinar su nivel personal de conocimientos sobre QMS y resolver cualquier deficiencia.
    3. Desarrollar una base sólida antes de obtener una certificación de calidad más avanzada.

    Reciba 13 créditos P.A.C.E. CE por su participación en el curso, después de completar el examen final.

    El CLSI es un proveedor de programas de educación continua en ciencias de laboratorio clínico del Programa ASCLS P.A.C.E.

    Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE

    Autora del curso

    Lucia Berte tiene experiencia de varios años como formadora y consultora en gestión de la calidad en el laboratorio. Es autora de muchos artículos, capítulos y libros, y ha organizado conferencias virtuales, talleres y cursos de aprendizaje sobre la gestión de la calidad en laboratorios médicos para distintas entidades de laboratorio profesionales. Hizo parte del equipo de elaboración de las últimas dos ediciones de la Norma ISO 15189 de laboratorios clínicos y ha desarrollado directrices, materiales educativos y programas de aprendizaje en línea sobre sistemas de gestión de la calidad en el laboratorio para el CLSI.