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

Angela Bazigos

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$349


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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.

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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: Angela Bazigos,

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PriceWaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry. More recently, Ms. Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ and is working with the FDA to define those metrics that will be used for compliance at the Boardroom level. She is also assisting the FDA with updating their guidance “General Principles of Software Validation” (published in 2002)


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