Online Webinar 2019 - Live Webinar Electronic Records & Electronic Signatures; 21 CFR Part 11

Overview
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. Today, more than 15 years after introduction, compliance with the requirements of Part 11 (as the regulation is now commonly referred to) continues to challenge the industry. As with any regulation, understanding the basic requirements is key to achieving compliance.
This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements, electronic records requirements and electronic signatures requirements.
Why should you attend
Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation. Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in efficiency...both efficiency in project management and avoidance of noncompliance penalties.
Session Highlights
History and Overview
Subpart A: General Provisions
Subpart B: Electronic Records
Subpart C: Electronic Signatures
Scope & Application Guidance
Questions and Answers
Who Wil Benefit
Project/Strategic Management
Quality Assurance Staff
IT Staff
Operations Staff
Speaker Profile
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.