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| HUM-MOLGEN -> Events -> Courses and Workshops | ||||||||||||||||
| IBC's Validating Commercial Off-the-Shelf Software for 21 CFR Part 11 Compliance | ||||||||||||||||
| March 28, 2003 | ||||||||||||||||
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-, Courtyard Hanover, Whippany, NJ May 8-9, 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. |
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| Organized by: | IBC Life Sciences | |||||||||||||||
| Invited Speakers: | Course Instructors: Janet Gough, Author, Consultant David Nettleton, Author, Consultant |
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| Deadline for Abstracts: | - | |||||||||||||||
| Registration: | Phone (508) 616-5550 x1004 Fax (508) 616-5522 E-mail reg@ibcusa.com On-line www.LifeSciencesInfo.com/2986 Mail IBC USA Conferences, Inc. One Research Drive, Suite 400A P.O. Box 5195 Westborough, MA 01581-5195 | |||||||||||||||
| E-mail: | reg@ibcusa.com | |||||||||||||||
| Posted by: | James G. Prudhomme | |||||||||||||||
| Host: | host-65-124-112-226.ibcusa.com | |||||||||||||||
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