Atlanta RAPS Chapter In Person Event: Annual Breakfast with FDA

Trang N. Cox

Supervisory Senior Advisor, OII / OMDRHI, FDA

Trang Cox began her career with FDA in 2009 as a Consumer Safety Officer in the Atlanta District Office. She was fast tracked and conducted technical and complex inspections for Medical Devices. Trang became Supervisory Consumer Safety Officer in 2014 in the Atlanta District Office and covered the Medical Device program and staff. Trang was also one of the New Hire Training cadre members and has worked co-operatively with other District’s management to perform the functions of a District Training Officer. Trang worked on her leadership skills and graduated from the first cohort of the Leadership Excellence Advancement Program (LEAP) in 2018. She was promoted to a GS-14 supervisor in 2018 and then Director of Investigations Branch in 2022. Trang Cox is a graduate of the University of Georgia with a background in Microbiology and Education.

James Hildreth

Supervisory Senior Advisor, OII / OMDRHI, FDA

James Hildreth is currently serving as the Supervisory Senior Advisor for the Office of Medical Devices and Radiological Health Inspectorate (OMDRHI), Division 2 – South, previously titled the Director of Investigations Branch (DIB) since 2022, and continues to provide direction and oversight to ensure the successful operation of the division’s four branches after reorganization in October 2024. Before working with Division 2, he served for eight (8) years in Portland, OR, as an FDA investigator principally focused on medical device and electronic product radiation controls (EPRC) inspections; in 2018, he accepted a position as a Supervisory Consumer Safety Officer overseeing medical device inspection staff located in the greater Los Angeles area who conducted foreign and domestic inspections to assure regulatory compliance of facilities manufacturing medical devices and radiological health products. Prior to government service, he obtained a Bachelor of Science in Biology from the Georgia Institute of Technology in Atlanta, GA.

LaReese Thomas

Branch Chief, OII / OHADI III, FDA

A firm believer in consumer protection and safety, Dr. LaReese Thomas has held a variety of roles at FDA spanning 15 years to realize his mission of ensuring safe and effective medical products to American citizens.  He enjoys his Agency privileges that include (but are not limited to): providing oversight to a team of skilled drug investigators performing highly technical inspections, making recommendations on the compliance status of critical application-based drug products, and fostering an inclusive work environment pivotal for strengthening employee morale.  Moreover, he effectively communicates with FDA Pharma leadership and industry stakeholders to promote successful interchange of ideas and collaborative methods.

Fred Lagud

Investigator, Biologics National Expert, OII / OBI / BGOS, FDA

Fred Lagud has been a Biologics National Expert (NE) in Biologics Global Operations Staff, since July 2024, answering technical questions from the Office of Biologics Inspectorate, reviewing and consulting on inspectional cases, performing high-visibility and cutting-edge inspections, and performing training in OBI national courses and conference calls. Inspections performed prior to becoming a Specialist in February 2000 mainly involved Blood Banks and Plasmapheresis Centers, human tissue recovery and processing and clinical trials. Since 2017, Fred has performed several seminal inspections of the emerging stem cell industry. More recently, Fred has worked with FDA’s Center for Veterinary Medicine on intentionally genetically altered animal products and animal cells, tissues, and cellular and tissue-based products. Fred joined FDA in June 1990, shortly after graduating from the University of Central Missouri with a BA in Biology.

Jennifer Coble

MPM, Regulatory Policy Analyst, CDRH Division of Standards and Conformity Assessment - ASCA Program, FDA

Jennifer Coble brings more than 25 years of experience in the clinical laboratory and pharmaceutical industries to her role at CDRH. Throughout her career, she held progressive leadership positions focused on Quality Management Systems and regulatory compliance, with expertise spanning laboratory and vendor audit program management, audit oversight, and regulatory readiness. Jennifer has also served as a strategic liaison between business units and regulatory teams, championing quality and compliance through cross-functional

education and engagement. She culminated her industry career leading regulatory compliance efforts for proprietary software medical devices navigating U.S. and EU requirements. Currently, Jennifer supports the ASCA program within CDRH, overseeing relationships with basic safety testing laboratories and educating industry on ASCA.

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