Live Webinar: Electronic Records & Electronic Signatures; 21 Cfr Part 11; Basic Concepts When: Wednesday November 3, 2021 - 03:00 PM Duration: 60 Minutes.
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 Part 11, 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. 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 non-compliance penalties.
History and Overview
Subpart A: General Provisions
Subpart B: Electronic Records
Subpart C: Electronic Signatures
Scope & Application Guidance
Questions and Answers
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