Binh T. Nguyen, Pharm.D., M.S. Reg Sci, BCSCP, FHPE is an independent biopharmaceutical expert with over 22 years of experience in biopharmaceuticals (injectables, oral dosage, topical, liquid, transdermal, & inhalers), biologics/biosimilars, compounding pharmacies, positron emission tomography, dietary supplements, combination products, compliance, pre-approval, and application assessment while at the US FDA. He has extensive experience sterile compounding, airflow, insanitary conditions and sterility assurance, stability and beyond use dating (BUD), investigations and CAPAs, supplier and contract qualification and management, and media fills. Nguyen has served as a subject matter expert in drug regulation interpretation pertaining to and impact on drug quality, manufacturing, and control worldwide. He has expertise in training, mentoring, coaching, and auditing drug specialists internationally. He received the FDA Commissioner’s Special Citation and numerous other high-level FDA Recognition Awards. He’s developing an inspection software to conduct self-audit using FDA and other regulatory bodies’ regulations with artificial intelligence to empower auditors.