Live Webinar Electronic Records & Electronic Signatures; 21 CFR Part 11; Basic Concepts

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

Electronic Records & Electronic Signatures

Description

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.

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 non-compliance penalties.

Areas Covered

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

Who will Benefit

?•     Project/Strategic Management
•     IT staff
•     Operations staff 
•     Quality Assurance staff

Industries who can attend

This 90-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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