Validation, the Key to Translatable Flow Cytometry, Part 3: Instrument Qualification
Recorded On: 10/29/2018
About the Presenter
Senior Scientific Manager
Flow Cytometry Biomaker Group
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.
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.
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