Speakers
Session 3: FDA Inspection Perspectives: What Investigators Evaluate and Common Readiness Gaps
Dr. Binh Nguyen is the founder and president of Wynngate Corporation, a GXP consulting firm. He retired from the FDA in March 2023 after more than 20 years specializing in bio/pharmaceutical training, compliance, management, and inspectional audits. During his FDA career, he served in roles including Level III certified pharmaceutical inspectorate, Level II drug auditor, Drug Branch Chief, and Director Regulatory Review Officer for biotech, sterile injectables, combination products, and other dosage forms.
Dr. Nguyen also practiced clinical hospital pharmacy for more than 23 years and served as a council member in sterile compounding pharmacy for the Board of Pharmacy Specialties. He holds a doctorate in pharmacy and a master’s degree in regulatory science. He is also the founder and developer of ieQip (intelligent electronic Quality Inspection Platform), an AI-based global inspection software, and currently serves as a course builder and instructor for the Parenteral Drug Association (PDA) and the University of Southern California’s regulatory program.