Reg-Savvy Foundations – See exactly how the FDA classifies flow cytometers and assays under device, laboratory, and investigational-use pathways so you can map your project to the right rule set.
Framework Fluency – Navigate 21 CFR Part 11, CLIA, GLP, and cGMP requirements—and understand how each one shapes data capture, instrument maintenance, and audit trails.
Submission-Ready Skills – Learn how flow data power INDs, BLAs, and companion-diagnostic filings, with checklists that keep potency, identity, purity, and safety assays on-spec.
Validation Confidence – Design studies for specificity, accuracy, precision, linearity, and LOD/LOQ in line with FDA and ICH Q2(R1) expectations, then translate them into rock-solid reports.
Assay Control Mastery – Build control strategies (including MRD and CDx workflows) that safeguard data integrity and satisfy electronic-records regulations.
$255.00
