FDA Speakers
Matthew Dionne, PharmD, MBA
Compliance Officer
OMQ | CDER | FDA
Matt Dionne is a pharmacist serving in the United States Public Health Service and Compliance Officer in the Office of Manufacturing Quality (OMQ) in the FDA’s Center for Drug Evaluation and Research (CDER). He received a Pharm.D. from the University of Rhode Island in 2001 and Master of Business Administration from Colorado State University in 2012. He joined FDA in 2006 and has experience in regulatory oversight and enforcement for a wide range of drug products from complex sterile injectables to topical over-the-counter products. He also led many of the CDER OMQ excipient initiatives related to the 2022-2023 international diethylene glycol and ethylene glycol poisoning.
Presentation Date/Time: Wednesday, May 6, 2 pm
Title: Safeguarding Against Diethylene Glycol Contamination: Lessons from Recent Outbreaks
Description: This session will review the recent Diethylene Glycol (DEG) contamination incidents in India that resulted in multiple pediatric fatalities linked to cough syrups. FDA will outline the root causes, including substitution of pharmaceutical-grade excipients with industrial chemicals, and discuss global regulatory responses, including WHO alerts and India’s enforcement actions. The presentation will highlight FDA’s preventive measures, such as guidance on glycerin testing, CGMP compliance, and international collaboration to protect the U.S. drug supply chain. Attendees will gain insights into risk mitigation strategies, supplier qualification, and analytical testing to prevent similar tragedies.
Adchara Pongpeerapat
Drug Product Quality Assessor
OPQ | CDER | FDA
Adchara Pongpeerapat, PhD, is a drug product quality assessor in the Office of Pharmaceutical Quality, CDER, FDA, with over 10 years of experience in Chemistry, Manufacturing, and Controls review for drug products. She specializes in complex drug product formulation and analytical method development. Her expertise includes excipient DMF Type IV review at the FDA. She serves as a government liaison to the Excipient Composition and Impurities Joint Subcommittee. She is passionate about advancing pharmaceutical quality standards and improving patient access to safe generic medications. Prior to joining the FDA, she gained valuable industry experience as a Formulation Scientist in the pharmaceutical industry and worked in the excipient industry, bringing practical knowledge to her regulatory role.
Presentation Date/Time: Wednesday, May 6, 8 am
Topic: FDA Perspective on Excipient Component Nomenclature and Excipient Composition
Description: This session will provide an overview of FDA’s approach to excipient component nomenclature and the role of compendial standards in ensuring quality and safety. The presentation will address regulatory expectations, common challenges in excipient composition reporting, and best practices for compliance with compendial requirements. Attendees will gain insights into FDA’s perspective on compendial modernization efforts and strategies to support accurate labeling and formulation transparency.
