Atlanta Chapter In Person Event: Annual Breakfast with FDA

FDA representatives will present the latest trends and hot topics. They will be on hand to take questions from the audience.

The agenda topics cover compliance trends for pharma, biologics, and medical devices. This event will start with a 7:30 AM breakfast and the presentation will start at 8:30 AM.

Registration Fees & Deadlines

Member $35 | Nonmember $50 | Student: $25

Speakers

Trang 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 joined FDA/KAN-DO in June 1990, shortly after graduating from the University of Central Missouri with a BA in Biology. Since joining FDA, Fred has led inspections of Blood Banks, Plasmapheresis Centers, and Biological Drug (Stem Cell) firms. Fred became the KAN-DO Biologics Specialist in February 2000 and has been certified in Blood Bank and Plasma inspections since 2003 and HCT/P Inspections since June 2024. He is a member of the foreign inspection cadre and is currently a CAG Member/Presenter for the BI225 Blood Bank and Plasmapheresis course and BI206 HCT/P course, as well as having presented at the BRIET Cohorts. Fred became a Biologics National Expert within the newly-reorganized Office of Inspections and Investigations (OII) in June 2024.   In his time away from FDA, Fred enjoys spending time with his wife Heather, and family, including five stepchildren and seven grandkids, bird-watching, traveling, and reading.

Jana Delfino
Deputy Division Director, OSEL/DIDSR, FDA

Bimal Amin
General Engineer, OSPTI / DDHP, FDA

Location

Arnall Golden and Gregory LLP
171 17th Street NW
Atlanta, GA 30363

Sponsors 

AGG
Donating the venue 

Mimedx
Donating food and drinks

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions