2020 Trends Related to 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

Date : 18th June 2020 to 18th June 2020

Place : United States, Aurora

Website :https://bit.ly/2TrqbCe

Contact Person:Training Doyens

Description:

Learn about the 21 CFR Part 11 regulations on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. Also learn about the policies and procedures to maintain data integrity.

2020 Trends Related to 21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA will be held in Aurora,United States on date 2020-06-18

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Deadline for abstracts/proposals : 18th June 2020

Keynote Speakers : Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

Conference Highlights :OVERVIEW 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 FDA 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. FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the p

Venue :Training Doyens, East Walker Drive, Aurora, CO, USA

Check the event website for more details.