Webinar On Electronic Records and 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.
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
Speaker Profile : Angela Bazigos
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance�. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is the president of PRCSQA.

Event Price Tags :

$ 219.00 Single Attendee
$ 689.00 Group – Max 10 Attendees per location
$ 249.00 Access Recorded Version online
$ 349.00 Buy Training CD-DVD

For More Details or Enrollment Or Registration :
Contact : complianzworld
Phone : +1-866-978-0800
Fax : +1-888-883-7697

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