Understanding the Impact of FDA’s 21 CFR Part 11 Rule Listen/download podcast (15:07 min)
This 15-minute podcast features an introduction to the FDA’s 21 CFR Part 11 Rule, a discussion of what it means, and its impact.
Chris PetriwManager, Computer Systems Validation, Covex, LLC
Chris has been performing validation in many different areas of the pharmaceutical industry for the past 10 years. Originally validating varying process control systems (DCS, SCADA, PLC) for many years, he has, in recent years, focused on laboratory validation systems (LIMS, CDAS). Chris is currently a Manager at Covex, LLC.
Denise BuckinghamLIMS Services Group Manager, Covex, LLC
Denise Covex became involved in her first LIMS implementation project in 1984 during her MIS internship at a State of Delaware environmental laboratory. Bringing the services focus of IS to the laboratory, she found her niche. After graduating from Loyola College with a Bachelors of Business Administration in MIS, Denise moved on to a LIMS support desk position at Perkin-Elmer which also provided her the opportunity to develop and present advanced feature training to LIMS customers.
She held positions at Computer Sciences Corporation, the Environmental Protection Agency, Applied Biosystems, and Applera before ultimately entering into consulting with Digital Consulting & Software Services. As an informatics consultant, Denise has worked on LIMS implementations for both regulated and non-regulated industries. She is currently manager of the LIMS Services Group for Covex, LLC.
Moderated by:
John Joyce, Ph.D. Contributing Editor. Scientific Computing
With a doctorate in analytical chemistry, John comes to SC via a convoluted route. After finishing playing with the 88" variable energy cyclotron at Texas A&M University, he spent 10 years with The Dow Chemical Company, where he ended up in the Analytical Sciences' Instrument Development & Automation Group. He is currently the LIMS manager for the Commonwealth of Virginia's Division of Consolidated Laboratory Services. In addition to writing Scientific Computing's monthly Tips & Techniques column, John also coordinates much of the magazine's LIMS/Laboratory Informatics coverage.
Listen/download podcast (15:07 min)