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Conference Details
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA (ntz)
Date :
Place : United States, Boston
Contact Person:Paula Edwards
Description:
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA (ntz) The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.21 CFR Part 11 Compliance for Computer Systems Regulated by FDA (ntz) will be held in Boston,United States on date 2018-01-26
Deadline for abstracts/proposals : 24th January 2018
Organized By :New York Events List
Keynote Speakers : Carolyn Troiano IT Program Manager and FDA Compliance Consultant, Smart Resources, Inc. Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology P
Conference Highlights :Why you should attend: This seminar will help you understand in detail the application of FDA's 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conc
Venue :Boston, MA, United States
Check the event website for more details.
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