1. Please tell us about yourself. What brought you to your current position?
I’m Dr. Binh Nguyen, the founder and president of a bio/pharmaceutical consulting firm, Wynngate Corporation. I retired from the US FDA in March 2023 after 20+ years, specializing in bio/pharmaceutical training, compliance, management, and inspectional audits for the Center for Drug Evaluation and Research (CDER) and Office of Inspections and Investigations (OII). I was a level III certified pharmaceutical inspectorate, a level II drug auditor, a drug branch chief, and director regulatory review officer for biotech, sterile injectables, combination products, and other dosage forms. I also practiced clinical hospital pharmacy for over 23 years.
I served as a council member in the sterile compounding pharmacy for the Board of Pharmacy Specialties for three years. I completed my doctorate in pharmacy and master’s in regulatory science at the University of Southern California (USC). I’m the founder and developer of an AI-based global inspection software, ieQip (intelligent electronic quality inspection platform). Currently, I’m a course builder and instructor for the Parenteral Drug Association (PDA), and I also teach at USC for their drug CGMP regulatory program.
2. What is your favorite part of the work you’ve done in this field?
My favorite part of my work is conducting inspections. The microbiology laboratory is an important operation supporting drug manufacturing, particularly liquid, inhalation, and sterile injectable products. People have had life-altering and irreparable effects from using microbiologically contaminated over-the-counter medication. This is just one of the many examples why microbiological controls are so critical.
Whenever I inspect manufacturing facilities, I focus heavily on microbiology coverage in every step—from methodology, following written procedure, conducting investigations, to addressing corrective actions, to name a few.
3. What is your talk about?
My talk is on the necessity of bioburden control: I discuss what bioburden is and its impact on finished drug product quality, along with steps to monitor it. I share areas where, when, and why controlling bioburden is critical. I go over examples of citations regarding inadequate or a lack of bioburden control to support the talk.
4. Why do you think it’s important to discuss this topic with our audience?
This topic is relevant to manufacturers using water in their manufacturing processes. It is all the more critical for facilities producing sterile finished drug products from non-sterile raw materials.
Dr. Binh Nguyen is the founder and president of a bio/pharmaceutical consulting firm, Wynngate Corporation. He retired from the FDA in March 2023 after 20+ years, specializing in bio/pharmaceutical training, compliance, management, and inspectional audits. He completed his doctorate in pharmacy and master’s in regulatory science at the University of Southern California (USC). He is currently a course builder and trainer for PDA (Parenteral Drug Association), and also teaches the drug CGMP regulatory program at the USC.
Register today for free to attend Binh’s and other insightful webinars at the 2025 Microbiology Week!
