Bringing It All Together
Part 3 of the Validation Webinar Series
Monday, September 10 at 12pm Eastern (U.S. & Canada)
Mission Viejo, CA
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.
In the final webinar of the Validation 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.
- 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