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FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11

Product Id: 1001

2 Days Left To REGISTER

Training Options

  • Thursday & Friday, April 27, 2017 |   09:00 AM to 06:00 PM |    Duration: 2 Days  
  • Refund Policy

Overview:

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting

This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:

  • What is Data Integrity and how is it implemented
  • How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
  • Data Integrity Frequently Asked Questions
  • Validation Master Plan
  • Risk Based Asssessment
  • Complete Validation for a System (software development lifecycle)
  • Automated Test Tools
  • Infrastructure Requirements
  • Change Control
  • SOPs

  • Who Should Attend:

    • VP of IT
    • Director of IT
    • Quality Managers
    • Project Managers (for DATA INTEGRITY / IT)
    • Validation Specialists
    • Database Administrators
    • System Administrators
    • Directors / Senior Directors of Discovery
    • Directors / Senior Directors of Development
    • Directors / Senior Directors of Commercialization
    • Document Managers
    • Training Managers
    • Consultants
    • Data Managers
    • Safety Managers
Speaker Profile
Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

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 Virtual Validation of Software. 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.


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