Regulatory clarity – Learn why and how flow assays must be validated under RUO, GLP, CLIA, cGMP, and IVD rules, and what each agency (FDA, CLIA, EMA) expects in a submission or inspection.
Validation toolkit – Confidently design studies for specificity, accuracy, precision, linearity, and LOD/LOQ—and know when robustness, stability, or carryover studies are non-negotiable.
Context-specific checklists – Distinguish the “must-haves” for an FDA BLA versus a CLIA‐validated LDT, so you never over- or under-validate.
Audit-ready documentation – Build traceable SOPs, raw-data packages, and summary reports that satisfy inspectors and streamline future re-validations.
Potency & identity assays – Validate CAR-T identity/viability/potency panels, applying spike-in recovery, reference methods, and appropriate FMO or isotype controls.
Reproducible analytics – Implement gating hierarchies and software settings that lock in consistency across operators, sites, and instruments.
Spectral vs. conventional insight – Compare validation nuances for spectral and conventional platforms, leveraging CLSI H62, MIFlowCyt, and other key guidelines.
Proof of mastery – Complete and pass a post-course quiz that verifies your ability to design, execute, and defend a compliant flow-cytometry validation plan.
$255.00
