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Quality Digest

FDA Compliance

Stelex Presents Training for FDA

Published: Tuesday, June 27, 2006 - 22:00

Stelex University recently provided a training session for the Food and Drug Administration’s National Center for Toxicology Research (NCTR) that focused on computer systems validation. Stelex University is Stelex’s professional education and technical training department. Its training session—which was requested by the FDA— was entitled “Computer Systems Validation in a Good Laboratory Practice Environment,” and it was presented to the NCTR group located in Jefferson, Arizona.

“The FDA does not normally go around asking people to come and train their staff, so when [it does], not only is it a rare opportunity, it is an honor,” says James Bardunias, Stelex University instructor.

Information technology at NCTR includes the use of computers for automated data collection systems, computational science analysis, and a state-of-the-art network infrastructure that includes servers, a high-speed LAN, and multiple T1 lines to the FDA in Maryland. Stelex’s training will help ensure that studies performed by NCTR are regulatory compliant and meet client or customer expectations.

Stelex provides enterprisewide compliance services and solutions to regulated industries, including the pharmaceutical, medical-device, diagnostic and biotechnology sectors. For more information, visit www.stelex.com.


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