Research Scientist III Eurofins Viracor BioPharma Lenexa, Kansas
An updated framework for GLP PCR validation and sample analysis will be presented. We will cover key method considerations, including how to evaluate required performance characteristics, determine the appropriate number of wells for sample analysis, and apply an internal control multiplex assay along with other essential assay controls. The presentation will also include a review of relevant best practice literature and regulatory guidance applicable to this context. We will conclude by discussing the questions that arose during the process and how we addressed them.
Learning Objectives:
Gain a clear understanding of the validation requirements for a qPCR assay, including the necessary workflow structure and the associated regulatory expectations.
