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


Starting at

$349


Buy Now

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. 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.

Course Objective

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.

Course Outline

  • History and Overview
  • Subpart A: General Provisions
  • Subpart B: Electronic Records
  • Subpart C: Electronic Signatures
  • Scope & Application Guidance
  • Questions and Answers

Target Audience

  • Project/Strategic Management
  • Quality Assurance staff
  • IT staff
  • Operations staff
  • Pharmaceutical, consumer products, and medical device companies, operating within the scope of FDA regulatory authority.
  • For FDA regulated companies, any staff members who may be involved with computerized system projects, validation of those systems, or have responsibility for maintenance/security of electronic records.  Additionally, staff members from companies which may develop software or computer systems for FDA regulated companies.
Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session




Follow us

24x7 Direct Number
(315) 632-0735,
(315) 750-4379
Toll Free
1-866-978-0800

Fax

1-888-883-7697