Part three: Regulatory considerations, validation strategies and emerging trends: qPCR/dPCR/ddPCR
In the final installment of this three-part series, Katherine navigates the regulatory landscape, assesses single-target vs multiplex workflows, and explores the key parameters for validating PCR assays in regulated bioanalytical laboratories.
About the speaker:
Katherine Veirs
Group Leader, TLM
QPS Holdings, LLC (DE, USA)
Katherine Veirs has more than 15 years of experience with the latest applied molecular techniques, including real-time PCR analysis, digital PCR (both ddPCR and dPCR), genomic sequencing (Sanger and Next Generation Sequencing) and PCR amplified MALDI TOF assays. She has experience with regulated testing under Clinical Laboratory Improvement Amendment (CLIA), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Additionally, she has served as a Principal Investigator for complex and basic method development, validation and sample analysis in pre-clinical and clinical studies, as well as serving as Technical and General Supervisor for CLIA testing.
Listen to other episodes in this series here.
Looking for more? Check out ‘The new frontier: the bioanalysis of cell and gene therapies’ podcast here.
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