HUM-MOLGEN events: IBC's Validating Commercial Off-the-Shelf Software for 21 CFR Part 11 Compliance

HUM-MOLGEN -> Events -> Courses and Workshops

IBC's Validating Commercial Off-the-Shelf Software for 21 CFR Part 11 Compliance

July 15, 2003

IBC Life Sciences, The Hilton at Dedham Place, Dedham, MA
September 9-10, 2003

This course presents a ten-step plan for validating all commercial off-the-shelf (COTS) software used to generate records and maintain data critical to the development, manufacture and distribution of drug products, medical devices, and biologics. Participants will learn the process from the initial determination of the need for COTS software, vendor selection and qualification, to the completion of a robust validation as well as what needs documentation and how to prepare it. By taking the mystery out of what inspectors look for and how to prepare for an FDA inspection, you can utilize efficient techniques for computer system validation that will reduce validation time and save resources.

Organized by:

IBC Life Sciences

Invited Speakers:

Course Instructors:

Janet Gough, Author, Consultant
David Nettleton, Author, Consultant

Deadline for Abstracts:

Registration:

Phone: (508) 616-5550 Fax: (508)616-5522 Email: reg@ibcusa.com Online: www.LifeSciencesInfo.com/2986

E-mail:

reg@ibcusa.com

Posted by:

James G. Prudhomme