FDA Medical Device Industry Coalition

Home Up Search Site Map Contact Us

Agenda

Agenda Speakers Reading

 

Join our mailing list. Click here!

Get Adobe Acrobat Reader Free!

FMDIC FDA Quality Systems Educational Forum: Production and Process Controls

bulletMorning general session
bulletIntroduction of program objectives by Mike Chappell
bulletRegulatory overview of Process and Production Controls by Monica Wilkins
bulletOverview of the Regulations
bulletWhy P&PC are Important
bulletFDA-483 Trends
bulletBusiness friendly view of P&PC by Krista Oakes and Stan Bauman
bulletCase studies by Cindy Walters and Monica Wilkins
bulletLunch
bulletAfternoon concurrent break-out sessions
bulletProduct acceptance (including statistical techniques and purchasing controls) by Margy Annes and Cheryl Boyce
bulletDevice history files by Scott Nichols and Bruce Horowitz
bulletSoftware validation by Dan Olivier and Norman Wong
bulletGeneral session wrap-up hosted by David Arvelo
bulletThe Small Business Representative Program
bulletQ&A panel

PowerPoint Shows (PPS) require Microsoft PowerPoint. Download viewer only if you don't have the full version of the program.

 

[ Home ] [ Up ]

Contact us with questions or comments about this web site.
Copyright © 2004 FDA Medical Device Industry Coalition
Last modified: 02/26/10