Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

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Category Hollywood

Deadline: March 05, 2020 | Date: March 05, 2020

Venue/Country: Florida, U.S.A

Updated: 2020-02-12 19:29:51 (GMT+9)

Call For Papers - CFP

With the emerging utilization of computerized technologies in the late 1980s and early 1990s, the pharmaceutical industry asked the FDA for guidance regarding compliance of the resulting electronic records. After several years of development and industry comments, 21 CFR Part11, the Electronic Records & Electronic Signatures Rule became law in 1997. Interestingly, as time passed other international regulatory agencies adopted similar e-records/e-signature regulations.

Session Highlights

History and Overview

Subpart A: General Provisions

Subpart B: Electronic Records

Subpart C: Electronic Signatures

Scope & Application Guidance

Questions and Answers

Speaker

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries.