CYTO U Upcoming Webinars
Collapse Validation, the Key to Translatable Flow Cytometry. Part 2: Method Validation- Planning and Executing

Validation, the Key to Translatable Flow Cytometry

Part 2

Method Validation- Planning and Executing

Monday, September 10 at 12pm Eastern (U.S. & Canada)

Presented by:

Teri Oldaker
Clinical Laboratory Scientist
San Clemente, CA

 

About the Presenter

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 drill-down to the specifics on how to conduct a validation. We will begin with an introduction to 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.

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

Who Should Attend

The target audience for the Validation series is everyone who is using flow cytometry and wants to generate high quality data (i.e. basic researchers, academia, pharma, biotech, clinical laboratories, environmental labs on boats, you name it).  You get the idea - everybody!

 

Formats Available: Streaming, Live Webcast + Streaming
Original Seminar Date: September 10, 2018
On-Demand Release Date: Available Now

Approved Credit:
  • ASCP: 1 hour CMLE

  • Topics & Pricing InformationTopics & Pricing Information Validation, the Key to Translatable Flow Cytometry. Part 2: Method Validation- Planning and Executing
    Collapse Validation, the Key to Translatable Flow Cytometry. Part 3: Instrument Qualification

    Validation, the Key to Translatable Flow Cytometry

    Part 3

    Instrument Qualification

    Monday, October 8 at 12pm Eastern (U.S. & Canada)

    Presented by:

    Cherie Green
    Senior Scientific Manager, Flow Cytometry Biomarkers
    Genentech
    San Francisco, CA

    About the Presenter

    Cherie has been a long standing 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: i) is installed properly and ii) 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.

     

     

     

    Formats Available: Streaming, Live Webcast + Streaming
    Original Seminar Date: October 08, 2018
    On-Demand Release Date: Available Now

    Approved Credit:
  • ASCP: 1 hour CMLE

  • Topics & Pricing InformationTopics & Pricing Information Validation, the Key to Translatable Flow Cytometry. Part 3: Instrument Qualification
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