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

Validation, the Key to Translatable Flow Cytometry

Part 3

Instrument Qualification

Monday, October 29 at 12pm Eastern (U.S. & Canada)

Presented by:

Cherie Green
Senior Scientific Manager, Flow Cytometry Biomarkers
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.




Seminar Information
Date Presented:
October 29, 2018 12:00 PM Eastern
1 hour
Registration Fee:
Instrument Qualification
Individual topic purchase: Selected
American Society for Clinical Pathology
CMLE: 1.00
ISAC Member Price: $0.00
Non-Member Price:$0.00