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

Mukesh Kumar
Jul 18, 2019 - 01:00 PM EDT
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$249


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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
Attend Live Webinar
Jul 18, 2019 - 01:00 PM EDT

Duration: 60 Minutes

Single Attendee


Group of 3 to 5


Group of 6 to 10 + DVD-USB


Training CD-DVD

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


Recorded video

Recorded video session



Speaker: Mukesh Kumar,

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.


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