News Release
FDA Contract Provides New Training Opportunities at BTEC
Media Contact(s)
Keith Nichols, News Services, (919) 515-7159
Rick Lawless, BTEC, (919) 513-0969
Oct. 25, 2007
FOR IMMEDIATE RELEASE
A new contract for the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University from the U.S. Food and Drug Administration (FDA) will benefit FDA trainees and North Carolina's biotech industry by smoothing the process of field inspections.
BTEC will design, develop and deliver pharmaceutical and biomanufacturing training for Office of Regulatory Affairs (ORA) field and operational personnel. The contract will pay BTEC $161,000 in the first year, and includes four additional option years, which would bring the total value of the contract to $455,000.
"Local industry could end up being the biggest winner, since BTEC students and industry employees will be able to learn pharmaceutical and biomanufacturing principles from the same faculty and trainers that deliver training to the FDA investigators," says Rick Lawless, BTEC's associate director of strategic support and project manager for the FDA contract. "Field inspections should be more effective because company officials and FDA investigators will speak a common language and have similar technical backgrounds."
The training will consist of distance-education learning modules and hands-on training at the new Golden LEAF BTEC facility on NC State's Centennial Campus. In addition to the high-tech facility and expert faculty, the FDA valued BTEC's focus on training versus contract manufacturing and NC State's ability to provide low-cost housing for on-site trainees.
BTEC will work closely with the FDA to produce courses that give participants exposure to pharmaceutical and biomanufacturing facility and equipment design issues, product development, manufacturing, and analytical testing methods. Trainees will gain experience in the same pharmaceutical and bioprocessing technologies that they inspect on a regular basis.
The Web-based training and hosting of the first FDA trainees is set for spring 2008.
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