Bringing It All Together

Part of the Validation Webinar Series

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

Presented by:

Teri Oldaker
Independent Consultant
Mission Viejo, 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 Councillor, 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 4 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. The course will begin with an introduction to the various regulated environments (CLIA, GLP, GMP, CGLP) and accreditation bodies (CAP, ISO).  Then we will discuss how to conduct the appropriate validation for each environment.  The fit-for-purpose and context-of-use concepts will be introduced. 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 final webinar of the series, you will learn the how to convert the principles learned in the first two webinars 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!

 

Live Webcast Information
Start Time:
September 10, 2018 12:00 PM Eastern
11:00 AM Central, 10:00 AM Mountain, 9:00 AM Pacific
Add to Calendar:
Estimated Length:
1 hour
Registration Time Remaining:
51 days, 6 hours
Registration Fee:
Free
Validation, Part 3: Bringing it All Together
Individual topic purchase: Selected
American Society for Clinical Pathology
CMLE: 1.00
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