Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts

Product Id : FDA160
Instructor : Angela Bazigos
Sep 19, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

Why Should You Attend:

The comprehensive testing and control of computerized systems is first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, “the system is down.” A well designed validation project will provide assurance of business continuity, and consequently provide assurance of regulatory compliance.

This presentation will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the basic concepts of validation, and describe the steps to be taken by a project team leading to a well-controlled and successful computerized system validation.

Learning Objectives:

  • Subpart A: General Provisions
  • Subpart B: Electronic Records
  • Subpart C: Electronic Signatures
  • Scope & Application Guidance

Session Highlights:

  • Introduction, Historical Perspective, and Definitions
  • Computerized System Validation Master Plan
  • Validation Plan
  • Developer Assessment
  • Requirements, Design, and Configuration Specifications
  • Validation Testing
  • Procedures/Archival/Traceability
  • Validation Summary Report
  • Commissioning Memo
  • System Decommissioning/Retirement
  • Questions & Answers

Who Will Benefit:

  • Project/strategic management
  • Quality assurance staff
  • IT staff
  • Operations staff
  • Staff members involved with computerized system validation project planning, validation testing, system use, system support, and regulatory compliance of computerized systems
Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer : http://morflearning.com/angelabazigos/, Director of QA and MIS Director.  Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA & DIA:

http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom : http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/

Includes training 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview  

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