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PDA-Innerspace Webinar - "Understand What Regulators Are Looking For: Analyzing FDA Data to Address Common Industry Challenges"

About this event

Event description:

Regulatory inspections can be stressful, with outcomes often unpredictable—even for well-prepared facilities. Non-compliance can lead to internal investigations, batch disposals, and contribute to drug shortages. Understanding what inspectors are looking for can help take preventive measures and avoid these risks.

Why Attend?

Join the webinar and learn from Binh Nguyen, an ex-FDA inspector with 20 years of experience, what really matters. He developed a platform that analyzes open FDA data to uncover the most common challenges pharmaceutical companies face during inspections.

We’ll explore these findings and provide strategies to help you avoid common pitfalls and align your operations with FDA expectations.

What you will learn:

  • The most commonly cited observations revealed by FDA data analysis.
  • What FDA inspectors are looking for.
  • The connection between training programs and drug shortages.

Join Binh Nguyen (Wynngate Corporation) and Chuck Gagnon (Innerspace) for a detailed dive into the behind-the-scenes world of regulatory inspections.


Agenda:

16:00 - 16:05 Welcoming and Speaker Introduction

16:05 - 16:35 Presentation by Binh Nguyen

16:35 - 17:30 Q&A and expert discussion

Hosted by

  • Guest speaker
    G
    Chuck Gagnon Key Account Manager @ Innerspace

    Chuck is an accomplished and results-driven sales leader with over 20 years of experience in key account management, business development, and sales strategy across diverse industries, including food processing, pharmaceuticals, and industrial sectors. He joined Innerspace early 2024 and is leading the US-Sales team.

  • Guest speaker
    G
    Binh Nguyen President @ Wynngate Corporation

    Dr. Binh Nguyen retired from the FDA in March 2024 after 20 years of specializing in pharmaceutical training, compliance, and inspectional audits for CDER (Center for Drugs Evaluation and Research) and ORA (Office of Regulatory Affairs). After retirement, he founded the Wynngate Corporation, a bio/pharmaceutical consulting firm, and developed ieQip, an AI-powered inspection software for audits. As Level III Certified Pharmaceutical Inspectorate and Level II Drug Auditor, Dr. Nguyen held key roles, including Drug Branch Chief and Director Regulatory Review Officer for biotech, sterile injectables, sterile compounding, positron emission tomography, combination products, and other dosage forms. He was also a clinical and compounding pharmacist at UCI Hospital for 21 years and served on the Board of Pharmacy Specialties’ sterile compounding counsel for 3 years. Dr. Nguyen earned a Doctorate in pharmacy and a Master’s in regulatory science from the University of Southern California.

  • Team member
    T
    Polina Kreneva Marketing and Community Manager @ Innerspace

Innerspace

Effective Cleanroom Training

Innerspace is breaking down the barriers in pharmaceutical manufacturing through blended training, objective assessment, and automated process modeling. Our goal is to create a world where more high-quality medicines reach patients faster.