Flow Cytometry: Validation and Implementation in a Regulatory Setting

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Presented by

Chelsea Riveley, MBA, Head of Business Development, Flow Cytometry Services

About this talk

This webinar provides an overview of flow cytometry and its potential uses in the regulatory setting. Two case studies will be presented to detail the unique aspects of conducting flow cytometry in both a preclinical and clinical regulated setting. The following phases of developing and validating a robust and reliable flow cytometry assay will be illustrated in this webinar: The critical steps to any flow cytometry assay – panel design, assay development, descriptions of validation test scripts that should be conducted along with suitable acceptance criteria, proper instrument set-up and appropriate controls, gating strategy and identification of cell subsets, and correct interpretation of flow cytometry data. Lastly, what to look for when choosing an outsourcing partner for flow cytometry will be discussed. These include some of the key decision points and factors to consider such as expertise, regulatory requirements, logistics, timelines, and price.

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