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FDA renews training contract for 2025

Published Sept. 19, 2024

Students and BTEC staff participating in the NIIMBL eXperience at BTEC
Participants in the Upstream and Downstream Bioprocessing course complete a hands-on activity with a bioreactor in BTEC's intermediate-scale fermentation lab.

Continuing a program that began in 2008, the U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) has renewed its training contract with BTEC for 2025. From March to August, a cohort of 15 FDA investigators will participate in two courses, Upstream and Downstream Bioprocessing and QC/Analytical and Aseptic Bioprocessing. When this newest cohort completes these courses, the program will have trained 245 FDA professionals.

BTEC’s courses for this program are designed to provide FDA investigators with a greater understanding of biopharmaceutical manufacturing principles and processes so that they can expand the scope of their inspections and determine areas of highest risk. The two courses are delivered sequentially in a hybrid format, with each nine-week course providing eight weeks of self-paced, online instruction followed by a week of intense, on-site learning in BTEC’s laboratories and classrooms in its main facility on Centennial Campus.

In 2025, the online portion of the Upstream and Downstream Bioprocessing course will begin March 10, while the on-site segment of the course will take place May 5–9. The QC/Analytical and Aseptic Bioprocessing course will begin online June 9, and on-site activities will take place Aug. 4–8. BioNetwork’s Capstone Center, located within the main BTEC facility, partners with BTEC to provide the aseptic processing portion of the QC/Analytical and Aseptic Bioprocessing course. BioNetwork is the life science training initiative of the North Carolina Community College System.

After completing each course, participants regularly report a much greater understanding of the subject matter. They also comment favorably on their hands-on laboratory experiences with BTEC’s industry-standard equipment and their interactions with instructors and laboratory personnel.

In addition to delivering courses for the FDA’s Office of Regulatory Affairs, BTEC previously provided a version of this same training program to 24 personnel from the agency’s Center for Drug Evaluation and Research. In addition, BTEC has delivered courses on cGMP biomanufacturing for vaccines to almost 70 FDA personnel.