How TGA, FDA & Other Regulatory Authorities Inspect Computerized Systems for Data Integrity 2017

  • 19-20 Oct 2017
  • Sydney, Australia

Description

Topics
  • How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
  • What is Data Integrity and how is it implemented?
  • Validation Master Plan
  • Data Integrity Frequently Asked Questions
  • Complete Validation for a System (software development lifecycle)
  • Risk Based Assessment
  • Infrastructure Requirements
  • Automated Test Tools
  • SOPs
  • Change Control
Who should Attend
  • Director of IT
  • VP of IT
  • Project Managers (for DATA INTEGRITY / IT)
  • Quality Managers
  • Database Administrators
  • Validation Specialists
  • Directors / Senior Directors of Discovery
  • System Administrators
  • Directors / Senior Directors of Commercialization
  • Directors / Senior Directors of Development
  • Training Managers
  • Document Managers
  • Data Managers
  • Consultants
  • Safety Managers

Past Events

Important

Please, check "How TGA, FDA & Other Regulatory Authorities Inspect Computerized Systems for Data Integrity" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Technology: Data management

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