Speakers
Mary Hole
Binh Nguyen
June-Mei Han
Event Schedule
Mary Hole is a Branch Chief with the U.S. Food and Drug Administration (FDA), where she oversees the San Jose Resident Post and leads a team of medical device investigators based in the San Jose Resident Post and Alameda District Office.
Before joining the FDA in 2010, Mary spent more than 20 years in the pharmaceutical industry, first as a chemist and later as a Regulatory Compliance Manager. She also established a consulting business focused primarily on Drug Enforcement Administration (DEA) regulatory compliance for controlled substances. At the FDA, Mary began as an Investigator conducting medical device inspections, became a Supervisor in 2016, and was appointed Branch Chief in 2023. The San Jose Resident Post includes investigators across multiple commodities, including Foods, Pharma, BIMO, Medical Devices, and Import Operations. Mary holds a bachelor’s degree in biology from San Jose State University and an MBA.
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.
June-Mei Han is the Chief of the Drug and Medical Device Compliance and Enforcement Section at the California Department of Public Health (CDPH) Food and Drug Branch. She has 24 years of experience with the branch, beginning her career in its food safety program. For the past 19 years, she has focused on pharmaceutical and medical device regulation and enforcement. June holds a degree in Molecular and Cell Biology from the University of California, Berkeley.
Stacey Masters has 19 years of experience with the California Department of Public Health (CDPH) Food and Drug Branch, with a focus on regulatory work across the drug, medical device, and cosmetic industries. She holds a Bachelor of Science in Nutrition from the University of California, Davis, and a Master of Public Health from Loma Linda University.