CBET partners with CSI to clarify federal regulations

Pharmaceutical, biotechnology and medical device industries must meet increased government regulation in the global market place. Success in the drug and medical device industries depends on accelerating the development and clinical testing process while meeting the quality standards for licensure and registration. Automated computer systems are essential to realizing this acceleration and must comply with (U.S. 21 CFR Part 11) regulations as well as validation standards.

To provide this vital training to the bioscience workforce in the Upstate New York region, CBET is very pleased to partner with Compliant Systems Integration, Inc., a company formed in 2004 to address a critical need in the pharmaceutical, biotech and medical devices industries to supply expertise in the area of FDA compliance. CSI’s strength lies in its 60 years combined experience integrating computer science with pharmaceutical science. In developing its partnership with CBET, CSI is committed to developing and presenting a series of workshops and seminars that will allow companies to improve performance, accelerate new product cycle times and achieve quality compliance necessary for successful licensure. In addition to 21 CFR Part 11, CBET will sponsor workshops on the following topics during 2006-2007: