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  • Contains 1 Component(s) Includes a Live Web Event on 08/23/2022 at 2:00 PM (EDT)

    Learn more about how CLSI's new product, Method Navigator, can help you to establish and implement laboratory test methods.

    In this free webinar, you will learn:

    • The purpose of CLSI's new product Method Navigator
    • List the 8 phases of the CLSI Test Life Phases Model
    • Describe how to use Method Navigator when establishing or implementing a new test method
    • You must log in to register
      • Non-member - Free!
      • Individual Student - Free!
      • Individual Associate - Free!
      • Individual Full Member - Free!
      • Industry Level III - Free!
      • Industry Level II - Free!
      • Industry Level I - Free!
      • HCPGOV Level III - Free!
      • HCPGOV Level II - Free!
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 3 Component(s), Includes Credits Includes a Live Web Event on 08/18/2022 at 1:00 PM (EDT)

    This comprehensive document covers all aspects for flow cytometry testing from the installation of the instrument to archiving the results. The target audience is anyone who touches a flow cytometer.

    CLSI H62, Validation of Assays Performed by Flow Cytometry

    August 18th, 1:00 PM US Eastern time

    The Clinical and Laboratory Standards Institute (CLSI) recently released the first edition of CLSI H62, Validation of Assays Performed by Flow Cytometry. This comprehensive document covers all aspects for flow cytometry testing from the installation of the instrument to archiving the results.  The target audience is anyone who touches a flow cytometer.

    The objective of this webinar is to provide guidance on how to distill the vast amount of information contained in this 234-page document into practice in the laboratory. Real-life examples of applying the document and practical suggestions will be provided.

    In this webinar, you will learn:

    • How to navigate the document;
    • How to plan an analytical method validation and create an assay validation protocol;
    • How to execute an analytical method validation;
    • How to streamline data analysis and report creation;
    • What to do when you have questions about CLSI H62

    Speakers:

    Dr. Virginia Litwin, PhD
    Charles River Laboratories

    Dr. Nithianandan Selliah, PhD
    Cerba Research

    Dr. Virginia Litwin, PhD

    Charles River Laboratories

    Virginia Litwin is a thought-leader in validation and standardization for flow cytometry. Bringing “Cytometry from Bench-to-Bedside” has been the focus of her professional activities since 1999 when she started working in translational medicine at Bristol-Myers Squibb. 

    She co-founded the Flow Cytometry Community within the AAPS. This group published the first papers on flow cytometry method and instrument validation. She was a councilor for the International Society for the Advancement of Cytometry (ISAC) and the International Clinical Cytometry Society (ICCS). She serves on the ICCS Advocacy Committee whose mission is to interface with regulatory agencies and has been an invited speaker at FDA/NIST on many occasions.

    Virginia is the chair of the Document Development Committee for the CLSI H62. She edited the book, Flow Cytometry in Drug Discovery and Development, as well as journal special issues: JIM- Flow Cytometry Biomarkers and Translational Medicine (2011); Cytometry Part B- Receptor Occupancy (2015); Cytometry Part B- Cytometry Advancing Next Generation Drug Development (2021).

    After obtaining a Ph.D. in Virology/Immunology from the University of Iowa, Virginia joined Lewis Lanier at DNAX as a post-doctoral fellow where she identified the KIR receptor, KIR3DL1 (CD158E1). She has held leadership roles in several contract research organizations. Currently she is a Research Scientist at Charles River Laboratories in Québec, Canada.

    https://www.linkedin.com/in/virginia-litwin-99869511

    https://twitter.com/VirginiaLi...

    Dr. Nithianandan Selliah, PhD

    Global Head of Flow Cytometry

    Cerba Research

    Nithianandan Selliah’s professional work spans academia, the biotech/pharma sector and most recently CROs. His Ph.D. research at the University of Kentucky focused on the effect of epinephrine in the modulation of T cell activation. After his PhD, he joined Dr. Terri Finkel’s lab at National Jewish Medical center to study the mechanism of by stander killing of CD4 T cells by HIV. This worked continued at the Children’s Hospital of Philadelphia. Later he conducted pioneering research in CAR T-cells for HIV therapy under the mentorship of Dr. Richard Junghans at Roger Williams Medical Center in Providence, RI. He then moved to a Biotech company to identify biomarkers for lupus disease utilizing flow cytometry. He joined Celgene to work on a specific project to explore therapeutic potential of red blood cells derived from in vitro differentiation of HSCs.

    In 2015, Dr. Selliah joined LabCorp drug development (formerly Covance) to help facilitate their expansion of flow cytometry supporting clinical drug development. He has developed and validated more than 10 flow cytometric methods which were deployed in numerous global clinical trials. His work has been represented at the International Clinical Cytometry Society (ICCS) Annual Course and the International Society for the Advancement of Cytometry’s annual meeting, CYTO. He has contributed to recommendation papers in Cytometry B and Current Protocols in Cytometry, and a chapter on receptor occupancy assays.

    He is an active member of the ICCS Quality and Standards committee whose mission is to create educational modules for the international flow cytometry community on standardizing processes for flow cytometry assays, including reagent quality testing and instrument standardization.

    Currently Dr. Selliah is the Global Head of Flow Cytometry at Cerba Research, where he leads a team of 12 scientists in developing and validating Flow cytometry assays for global clinical trials. 

    • You must log in to register
      • Non-member - $30
      • Individual Student - $22.50
      • Individual Associate - $25.50
      • Individual Full Member - $22.50
      • Industry Level III - $15
      • Industry Level II - $12
      • Industry Level I - Free!
      • HCPGOV Level III - $15
      • HCPGOV Level II - $12
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 3 Component(s), Includes Credits

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

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

    Moderator:
    Janet Hindler, MCLS MT(ASCP)F(AAM), Los Angeles County Department of Health

    Speakers include:
    Romney Humphries, PhD, D(ABMM), Medical Director, Clinical MIcrobiology, Vanderbilt University Medical Center
    Jean B. Patel, PhD, D(ABMM), Principal Scientist, Microbiology, Beckman Coulter
    Dmitri Iarikov, MD, PhD, Deputy Division Director, FDA Center for Drug Evaluation and Research
    Natasha Griffin, PhD, Lead Biologist, FDA Center for Devices and Radiological Health


    • You must log in to register
      • Non-member - Free!
      • Individual Student - Free!
      • Individual Associate - Free!
      • Individual Full Member - Free!
      • Industry Level III - Free!
      • Industry Level II - Free!
      • Industry Level I - Free!
      • HCPGOV Level III - Free!
      • HCPGOV Level II - Free!
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 3 Component(s), Includes Credits

    Based on CLSI document NBS01, Dried Blood Spot Specimen Collection for Newborn Screening, 7th edition, this video demonstrates how to: • Prepare for specimen collection. • Collect blood specimens using the recommended heelstick technique. • Handle specimens properly and maintain appropriate records. • Transfer specimens to the screening lab in a timely manner. • Prevent testing problems that can delay the newborn’s diagnosis and treatment.

    Based on CLSI document NBS01, this video demonstrates how to:

    • Prepare for specimen collection.
    • Collect blood specimens using the recommended heelstick technique.
    • Handle specimens properly and maintain appropriate records.
    • Transfer specimens to the screening lab in a timely manner.
    • Prevent testing problems that can delay the newborn’s diagnosis and treatment.

    0.5 P.A.C.E. credits are available for this course.

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

    • You must log in to register
      • Non-member - $100
      • Individual Student - $75
      • Individual Associate - $85
      • Individual Full Member - $75
      • Industry Level III - $50
      • Industry Level II - $40
      • Industry Level I - $30
      • HCPGOV Level III - $50
      • HCPGOV Level II - $40
      • HCPGOV Level I - $30
      • Health System - $30
      • CLSI Staff - Free!
    • More Information
  • Contains 6 Component(s), Includes Credits

    This on-demand, four module course is based on CLSI document QMS15, Internal Auditing. Receive 4 P.A.C.E. credits upon successful completion of the course.

    This on-demand, four module course is based on CLSI document QMS15, Laboratory Internal Audit Program, 2nd edition.
    In this course, you will learn:
    • - The five reasons for having a laboratory internal audit program
    • - The requirements for a laboratory internal audit program
    • - The elements of a laboratory internal audit program
    • - The process flow for conducting an internal audit of a specified laboratory process
    • - The elements of an effective audit report and the source of information for each
    • - How to formulate an effective audit report
    • - How to describe appropriate auditee responses to audit findings
    • - How to evaluate the effectiveness of a laboratory internal audit program

    Receive 4 P.A.C.E. credits upon successful completion of the course.

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

    • You must log in to register
      • Non-member - $149
      • Individual Student - $111.75
      • Individual Associate - $126.65
      • Individual Full Member - $111.75
      • Industry Level III - $74.50
      • Industry Level II - $59.60
      • Industry Level I - $44.70
      • HCPGOV Level III - $74.50
      • HCPGOV Level II - $59.60
      • HCPGOV Level I - $44.70
      • Health System - $44.70
      • CLSI Staff - Free!
    • More Information
  • Contains 6 Component(s), Includes Credits

    Recorded on Thursday, May 26, 2022

    CLSI EP26: User Evaluation of Acceptability of a Reagent Lot Change

    Recorded on Thursday, May 26, 2022 

    Following this presentation you will be able to:

    •  Discuss the importance of verifying reagent lot changes.
    •  Outline how to design an effective reagent lot change study.
    •  List the steps in conducting a reagent lot change study.

    Speakers:

    Lorin Bachmann, PhD, DABCC
    Co-Director Clinical Chemistry, Virginia Commonwealth University Health System

    Nils Person, PhD, FAACC
    Independent Consultant

    Jesper Johansen, PhD
    R&D Senior Specialist, Metrology and Statistics, Radiometer Medical ApS

    Cost: $30.00 per person. Member discounts apply; free for Level I & Health System members.

    Earn 1.0 P.A.C.E.® CE Credit.
    CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

    • You must log in to register
      • Non-member - $30
      • Individual Student - $22.50
      • Individual Associate - $25.50
      • Individual Full Member - $22.50
      • Industry Level III - $15
      • Industry Level II - $12
      • Industry Level I - Free!
      • HCPGOV Level III - $15
      • HCPGOV Level II - $12
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 7 Component(s), Includes Credits

    What's New in the 2022 CLSI Standard for Antimicrobial Susceptibility Testing (AST)?

    Presented on March 23, 2022

    Moderator:
    Janet A. Hindler, MCLS MT(ASCP) F(AAM)
    Los Angeles County Department of Health
    Los Angeles, CA

    Speakers:
    Romney M. Humphries, PhD, D(ABMM)
    Professor, Pathology, Microbiology and Immunology
    Medical Director, Clinical Microbiology
    Vanderbilt University Medical Center
    Nashville, TN

    Audrey Schuetz, MD, MPH, D(ABMM)
    Professor of Laboratory Medicine and Pathology
    Division of Clinical Microbiology
    Mayo Clinic College of Medicine and Science
    Rochester, MN

    • You must log in to register
      • Non-member - $99
      • Individual Student - $74.25
      • Individual Associate - $84.15
      • Individual Full Member - $74.25
      • Industry Level III - $49.50
      • Industry Level II - $59.40
      • Industry Level I - Free!
      • HCPGOV Level III - $49.50
      • HCPGOV Level II - $59.40
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 7 Component(s), Includes Credits

    What's New in the 2022 CLSI Standard for Antimicrobial Susceptibility Testing (AST)?

    Presented on March 22, 2022

    Moderator:
    Janet A. Hindler, MCLS MT(ASCP) F(AAM)
    Los Angeles County Department of Health
    Los Angeles, CA

    Speakers:
    Romney M. Humphries, PhD, D(ABMM)
    Professor, Pathology, Microbiology and Immunology
    Medical Director, Clinical Microbiology
    Vanderbilt University Medical Center
    Nashville, TN

    Audrey Schuetz, MD, MPH, D(ABMM)
    Professor of Laboratory Medicine and Pathology
    Division of Clinical Microbiology
    Mayo Clinic College of Medicine and Science
    Rochester, MN

    • You must log in to register
      • Non-member - $99
      • Individual Student - $74.25
      • Individual Associate - $84.15
      • Individual Full Member - $74.25
      • Industry Level III - $49.50
      • Industry Level II - $59.40
      • Industry Level I - Free!
      • HCPGOV Level III - $49.50
      • HCPGOV Level II - $59.40
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information
  • Contains 147 Component(s), Includes Credits

    This online, self-paced Laboratory Quality Management System Certificate Program describes the skills needed for successful implementation and sustainment of a quality management system (QMS) in your laboratory.

    This online, self-paced Laboratory Quality Management System Certificate Program describes the skills needed for successful implementation and sustainment of a quality management system (QMS) in your laboratory.

    This program focuses on providing a systematic, process-oriented approach to meeting quality objectives, and delivering consistent, high-quality, cost-effective laboratory services through the implementation of a QMS.

    Upon completion of this online training course, participants will be able to ensure that their laboratories:
    • Meet accreditation quality requirements.
    • Run with the highest efficiency and productivity.
    • Provide the highest quality test results to their patient population.

    Intended Audience: Quality Officers and Managers, Laboratory Managers, Laboratory Technical Staff

    Earn 13 P.A.C.E.® CE Credits.
    CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

    All materials in this course are copyrighted.
    ©2020 Clinical and Laboratory Standards Institute. All rights reserved.

    • You must log in to register
      • Non-member - $750
      • Individual Student - $562.50
      • Individual Associate - $637.50
      • Individual Full Member - $562.50
      • Industry Level III - $375
      • Industry Level II - $450
      • Industry Level I - $150
      • HCPGOV Level III - $375
      • HCPGOV Level II - $450
      • HCPGOV Level I - $150
      • Health System - $150
      • CLSI Staff - Free!
    • More Information
  • Contains 5 Component(s), Includes Credits

    Recorded on Thursday, April 28, 2022 at 1:00 PM US Eastern Time

    CLSI M39: Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data

    Thursday, April 28, 2022 

    Learn about CLSI's updated M39 document, Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. At the conclusion of this presentation, the attendee will be able to:

    • List the M39 5th edition recommendations for preparation and use of a routine antibiogram.
    • Explain the value of antibiograms in antimicrobial stewardship decision making.
    • Discuss expanded applications of antibiograms to include multifacility, veterinary and LTCF antibiograms.

    Speakers:
    Patricia (Trish) J. Simner, PhD, D(ABMM)
    Associate Professor of Pathology and Infectious Diseases 
    Director of Bacteriology and Infectious Disease Sequencing Laboratories,
    The Johns Hopkins University School of Medicine, Baltimore, MD

    Kate Dzintars, PharmD, BCPS-AQ ID
    Clinical Pharmacy Specialist, Infectious Diseases
    Associate Pharmacy Director, Antimicrobial Stewardship Program
    The Johns Hopkins Hospital, Baltimore, MD

    Cost: $30.00 per person. Member discounts apply; free for Level I & Health System members.

    Earn 1.0 P.A.C.E.® CE Credit. CLSI is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.

    • You must log in to register
      • Non-member - $30
      • Individual Student - $22.50
      • Individual Associate - $25.50
      • Individual Full Member - $22.50
      • Industry Level III - $15
      • Industry Level II - $12
      • Industry Level I - Free!
      • HCPGOV Level III - $15
      • HCPGOV Level II - $12
      • HCPGOV Level I - Free!
      • Health System - Free!
      • CLSI Staff - Free!
    • More Information