The United States Food and Drug Administration (FDA) exercised the option to extend its training contract with the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University for another year. The total contract is now just over $229,000, but could reach $455,000 if the last three option years are exercised.
Last year, BTEC developed and delivered biomanufacturing training for Office of Regulatory Affairs (ORA) field and operational personnel. During this first option year, BTEC will offer additional training, including a course that will be taught by faculty from Wake Technical Community College in the North Carolina Community College System BioNetwork Capstone Center, housed in the Golden LEAF BTEC facility on NC State’s Centennial Campus.
 
“FDA trainees have been excited about the hands-on laboratory activities that make-up almost 75% of our courses,” says Rick Lawless, BTEC’s Associate Director of Strategic Support and project manager for the FDA contract. “Field personnel now have a much better appreciation for the complexity of biomanufacturing operations and how and why some of these operations can be so challenging.”
 
Before attending each hands-on training session at BTEC, FDA trainees must complete four weeks of comprehensive Web-based training. Many complete this training in their off-hours while on the road conducting field inspections. Even though the courses are rigorous, ORA officials have indicated that demand for the BTEC courses is high.    
 
To help the FDA meet its recruitment and training goals, BTEC staff is working on ways to increase the FDA’s access to NC State students looking for a career in the regulatory field. NC State students that take courses at BTEC use the same pilot-scale equipment and learn the same basic concepts as the FDA trainees. As an initial step, the FDA participated in the BTEC Career Fair on March 20. 
 
Contact:   Rick Lawless, BTEC, (919) 513-0969