Validation, the Key to Translatable Flow Cytometry

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Instrument qualification and method validation are two of the pillars required for obtaining cytometry data that are reliable and suitable for decision making. In this three-part webinar series all aspects of validation for flow cytometry, from the instrument to the assay, will be covered.  

Validation, the Key to Translatable Flow Cytometry, Part 1: Method Validation—Overview, Concepts

Validation, the Key to Translatable Flow Cytometry, Part 2: Method Validation—Planning and Executing

Validation, the Key to Translatable Flow Cytometry, Part 3: Instrument Qualification

  • Validation, the Key to Translatable Flow Cytometry, Part 3: Instrument Qualification

    Contains 4 Component(s), Includes Credits Recorded On: 10/29/2018

    A CYTO U Webinar presented by Cherie Green

    About the Presenter

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    Cherie Green
    Senior Scientific Manager
    Flow Cytometry Biomaker Group
    Genentech

    Cherie Green has been a member of the cytometry community for over 20 years working in hematopathology and biotech laboratories. She is passionate about development of robust biomarker assays to support all phases of drug development. Currently, she oversees the Flow Cytometry Biomarker Group in the Development Sciences department at Genentech, a member of Roche Group in San Francisco, CA. Her group is responsible for the development and validation of clinical biomarker assays in the areas of infectious, autoimmune, and oncology diseases. She has served as the co-chair of Flow Cytometry Action Committee of the American Association of Pharmaceutical Scientists (AAPS) and has co-authored many consensus/recommendation papers on topics specific to drug development such as instrument and assay validation, sample stability, and receptor occupancy. 

    Webinar Summary

    The foundation of good data starts with the instrument. While substantial effort is often invested in development and validation of analytical methods or analysis, instrument validation is often neglected. It is essential to apply the same analytical and scientific rigor to the platform generating the data. From initial optimization and characterization of performance to establishing QC systems to ensure longitudinal data comparability, instrument validation strategies are critical components of generating robust and reliable data. This is true for all laboratory environments but particularly relevant for regulated labs providing decision-enabling biomarkers. Generating quality data plays a critical role in bringing new therapeutic options to the medical community—drugs which eventually manifest as successful new treatments for those individuals afflicted with disease.

    Learning Objectives

    In this webinar, you will learn the basic principles of instrument validation. Validation of flow cytometers used in regulated environments provides assurance that the output generated on these instruments is reproducible and precise. The most relevant elements of instrument validation include testing to verify that an instrument is installed properly and performs as intended. This includes establishing controlled procedures for installation, maintenance, calibration, cross-instrument standardization, and longitudinal performance monitoring. This course will review basic concepts of instrument validation and provide examples of each step in the process that can be applied in your lab.

    Who Should Attend

    Anyone interested in getting robust and reliable flow cytometry data.

    CMLE Credit: 1.0

  • Validation, the Key to Translatable Flow Cytometry, Part 2: Method Validation - Planning and Executing

    Contains 4 Component(s), Includes Credits Recorded On: 09/10/2018

    A CYTO U Webinar presented by Teri Oldaker

    About the Presenter

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    Teri Oldaker
    Clinical Laboratory Consultant

    Teri is a licensed clinical laboratory scientist and certified cytometrist with over 40 years clinical laboratory and 34 years flow cytometry experience in reference laboratory settings.  She is currently in a consultant role for a number of clinical laboratories. Her prior roles include director of flow cytometry at Genoptix, Neogenomics, Genzyme Genetics, and Nichols Institute. Teri has served on the board of the International Clinical Cytometry Society (ICCS) as secretary/treasurer and councilor, and is on the faculty of both the ICCS and Clinical Cytometry Education Network (CCEN) Flow Courses. She is a member of the following ICCS committees: Advocacy, Certification, and Quality and Standards Committees. She has authored four book chapters and over 40 publications in the field of flow cytometry.

    Webinar Description

    This webinar will review the specifics on how to conduct a validation. We will begin with an introduction of the various regulated environments and accreditation bodies requiring assay validation. Then we will discuss how to conduct the appropriate validation for each environment. The distinction between assay qualification and validation will be reviewed. Various strategies to designing method validation protocols will be discussed. These recommendations will be aligned with the upcoming Clinical Laboratories Standards Institute (CLSI) guidelines regarding the number of samples, number of analytical runs, data analysis, and acceptance criteria. Examples of a biomarker validation and a clinical laboratory validation will be presented. Lastly, an update on the progress of a regulatory guidance document for the validation of flow cytometric methods will be presented.

    Learning Objectives

    In the second webinar of the series, you will learn the how to convert the principles learned in the first webinar into practice in your own laboratory. We will describe what you actually need to do to validate a method.

    • An introduction to the different types of regulatory environments.
    • Gain an understanding of the difference between assay development, optimization, and validation.
    • Gain an understanding of the fit-for-purpose and context-of-use validation approaches.
    • Learn to prepare user-friendly documentation.

    Who Should Attend

    Anyone using flow cytometry who wants to generate high-quality data.

    CMLE Credit: 1.0

  • Validation, the Key to Translatable Flow Cytometry, Part 1: Method Validation - Overview, Concepts

    Contains 4 Component(s), Includes Credits Recorded On: 08/13/2018

    A CYTO U Webinar presented by Virginia Litwin, PhD

    About the Presenter

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    Virginia Litwin, PhD
    Vice President, Immunology
    Caprion Biosciences Inc.

    Virginia Litwin is a thought leader in analytical method validation 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 Action Program Committee (APC) within the American Association of Pharmaceutical Scientists (AAPS). The Flow Cytometry APC published the first papers on flow cytometry method and instrument validation, which Virginia was invited to present at the FDA Workshop on Clinical Flow Cytometry in 2013. Virginia is the chair of the Document Development Committee for a new Clinical Laboratory Standards Institute (CLSI) Guideline, H62: Validation of Assays Performed by Flow Cytometry. She is a councilor for both the ISAC and the International Clinical Cytometry Society (ICCS). In addition, she serves on the ICCS Advocacy Committee, whose mission is to interface with regulatory agencies.

    Webinar Summary

    This webinar will include an introduction of the concepts of analytical method validation. For flow cytometric assays, validation carries unique requirements owing to the challenges associated with measuring cells, the lack of cellular reference materials, and the complexity of the instrumentation. The focus of this webinar will be on how to apply the basic validation principles to flow cytometry and why guidelines appropriate to other methodologies cannot fully be applied to flow cytometry. One of the most challenging and contentious, but also most important, aspects of cell-based assay validation surrounds the demonstration of method accuracy and linearity. These points will be addressed in depth.

    Learning Objectives

    In this webinar, you will learn the basic principles of analytic method validation. We will define each of the validation parameters, and how those parameters can be addressed in flow cytometry method validation. We will also discuss how to interpret the validation data once it is generated and how the validation data influences the final use of the data.

    • Gain an understanding of the purpose of method validation.
    • Learn the basic validation parameters.
    • Gain an understanding of specific validation considerations for flow cytometry.
    • Gain an understanding of how the type of data generated in the assay influences the design of the method validation.
    • An introduction to interpreting validation data.

    Who Should Attend

    Anyone using flow cytometry who wants to generate high quality data.

    CMLE Credit: 1.0