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Training Options

  • Wednesday & Thursday, June 7, 2017 |   09:00 AM to 06:00 PM |    Duration: 2 Days  
  • Refund Policy


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
Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website

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