– Gained foundational understanding of how flow cytometry is regulated by the FDA under device,
laboratory, and investigational use pathways.
– Identified key regulatory frameworks including 21 CFR Part 11, CLIA, GLP, and GMP as they apply to
flow cytometry.
– Explored the application of flow cytometry in investigational new drug (IND) and biologics license
application (BLA) submissions.
– Understood the validation requirements for flow cytometry assays per FDA and ICH guidelines (e.g.,
ICH Q2(R1)).
– Recognized the role of flow cytometry in potency, identity, purity, and safety testing for cell and gene
therapy products.
– Reviewed FDA expectations for companion diagnostics (CDx) and minimal residual disease (MRD)
monitoring using flow cytometry.
– Learned best practices for assay control strategies, data integrity, and electronic records compliance in
regulatory submissions.
$9.99
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SuperNova Flow Cytometry is an independent educational provider with no affiliation, endorsement, sponsorship, and/or connection to Beckman Coulter, Inc. or Beckman Coulter, Inc.’s SUPERNOVA flow cytometry products.