Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Matthew M. Lowe
Don’t wait until something bad happens to make a change
Kari Miller
A lack of integration hampers quality compliance across a product’s life cycle
Etienne Nichols
A well-defined CAPA program is a framework for quality and effectiveness
Grant Ramaley
IAF CertSearch now mandatory for accredited certification bodies
Etienne Nichols
What’s the difference?

More Features

FDA Compliance News
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community

More News

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.

Discuss

About The Author

Quality Digest’s picture

Quality Digest

For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.