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  • Contains 2 Component(s) Recorded On: 11/08/2022

    Helpful information about your CLSI membership will be presented in this Webinar for delegates and alternate delegates.

    Helpful information about your CLSI membership will be presented in this Webinar for active CLSI Delegates and Alternate Delegates, including: 

    • Who CLSI is, how we make a difference, and who our members are.
    • An introduction to our new CEO, Barb Jones, PhD.
    • Your role as a Delegate.
    • A volunteering general overview.
    • A high-level membership benefits review.
    • A step-by-step walkthrough of “My CLSI.”
    • A demo of our online library, eCLIPSE.
    • Accreditation resources.
    • New CLSI documents and products.
    • Upcoming publications and products. 

    Barb Jones, PhD

    CEO, CLSI

    Clinical and Laboratory Standards Institute

    Dr. Barb Jones was appointed as Chief Executive Officer of CLSI on May 15, 2022. She is the third CEO in CLSI's 54-year history. Dr. Jones’ experience includes operations leadership, laboratory management, pharmaceutical and quality standards development, regulatory policy, and business development at both the national and international levels. Prior to her role as CLSI’s CEO, Barb was Senior Vice President, Scientific Operations and Regulatory Affairs at Vyant Bio in San Diego, California.

    In her role as Vice President at the United States Pharmacopeia (USP), Dr. Jones directed the work of more than 200 global scientists and oversaw the “Gold Standard” for reference materials for the US and more than 150 countries worldwide. As a scientist and researcher for the National Institute of Standards and Technology (NIST), she served as Science Advisor for the Biochemical Sciences Division, and was appointed by the NIST Director as Advisor to the US House of Representatives Committee on Science and Technology. In this role, she developed analytical techniques for lab-on-a-chip technology and coordinated the expansion of chemical and biological weapons counterterrorism standards for the US Department of Homeland Security.

    Additionally, she has provided critical advisement on the viability of acquisitions and technologies, particularly in pharmaceutical and medical device and diagnostic development. She also has advised international policy makers, key scientists, and business leaders around the world on pharmaceutical standards, laboratory practices, proficiency, and regulatory compliance.

    Dr. Jones received her Doctorate in Analytical Chemistry from Arizona State University and was awarded a prestigious National Research Council postdoctoral fellowship at NIST.

    Katie Barnett

    Director, Membership and User Experience, CLSI

    Clinical and Laboratory Standards Institute

    Katie Barnett is CLSI's Director of Membership and User Experience and has been with CLSI for the past 14 years. She previously held the positions of Membership Director and Manager of Membership and Marketing.

    Jessica Chumaceiro

    Customer Relationship Manager, CLSI

    Clinical and Laboratory Standards Institute

    Jessica Chumaceiro is CLSI's Customer Relationship Manager. Her responsibilities include building, retaining, maintaining, and fostering relationships between CLSI and its stakeholders, including members, customers, volunteers and vendors.

    • 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 Recorded On: 09/27/2022

    Learn how to use the 4th edition of EP14--Evaluation of Commutability of Processed Samples. EP14 provides guidance for evaluating the commutability of processed samples for determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.

    Using EP14: Evaluation of Commutability of Processed Samples

    September 27, 1:00 PM US Eastern time

    Learn how to use the 4th edition of EP14--Evaluation of Commutability of Processed Samples. EP14 provides guidance for evaluating the commutability of processed samples for determining if they behave differently than unprocessed patient samples when two quantitative measurement procedures are compared.

    Learning Objectives:

    • Understanding commutability
    • Determine which type of processed samples may need to be evaluated for commutability
    • How to design the commutability evaluation study, including acceptance criteria
    • Running the study, then reviewing the results to see if data transformations are needed
    • Analyzing the data and evaluating commutability

    Speaker: Jeffrey R. Budd, PhD

    Jeffrey R. Budd, PhD

    Dr. Budd received his PhD in Biometry and Health Information Systems from the University of Minnesota. His entire career has been directed toward improving clinical diagnostics in lung function, cardiac electrophysiology, home health monitoring and finally in vitro diagnostics (IVD). He was Principal Biostatistician at Beckman Coulter for 20 years from which he retired 2 years ago.

    Besides an IVD biostatistical consulting practice, Dr. Budd actively participates in developing IVD international guidelines. This includes membership in the ISO TC212 working group 2 which published 17511 on metrological traceability and the IFCC working group on reference material commutability which published a series of papers on this topic. He also plays active roles in CLSI including as a member of the EP Expert Panel; as chair of the document development committees (DDC) for EP09 on measurement procedure comparison, EP12 on qualitative examinations and EP30 on commutable reference material; and as member of the DDCs for EP14 on processed sample commutability and for EP32 on metrological traceability.


    • You must log in to register
      • Non-member - $30
      • Individual Student - $22.50
      • Individual Associate - $22.50
      • 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 2 Component(s) Recorded On: 08/23/2022

    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 be able to:

    • Understand 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.

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

    Laboratories Made Better!

    Ms. Berte has a bachelor’s degree in Medical Technology and a master’s degree in Health Care Administration. In addition to being an ASCP-certified Medical Technologist, Specialist in Blood Banking, and Diplomate in Laboratory Management, she is also certified as a Quality Manager and Quality Auditor by the American Society for Quality.

    Ms. Berte has been the author of numerous articles, chapters, and books and continues to provide learning programs on various aspects of laboratory quality management. She has volunteered for CLSI for 30 years and has served as chairholder and member of past and current CLSI document development committees and was one of the developers of the Method Navigator product you will see today.


    Tabitha Kern, MS, MLS (ASCP)CM

    CLSI

    Ms. Kern is a director of Standards Development and Project Administration at CLSI and has been apart of the organization for over three years. She has her Master’s degree in Medical Laboratory science and is an ASCP-certified Medical Laboratory Scientist. Prior to CLSI she spent 12 years working in an Immunology and Flow Cytometry medical laboratory. Her project focus has been on documents in Method Evaluation area. Ms. Kern has helped with the development and implementation of this novel product.

    • 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

    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

    Recorded on: 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