FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11 2017

  • 19-20 Apr 2017
  • Hilton Zurich Airport, Switzerland

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 Asssessment
  • Infrastructure Requirements
  • Automated Test Tools
  • SOPs
  • Change Control
Who should Attend

Attendees with job titles such as:

  • 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 Development

Past Events

Important

Please, check "FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Quality assurance, Security & Safety
Health & Medicine: Healthcare
Industry: Food & Beverages
Science: Life Sciences & Biology
Technology: Data management, Information Technology (IT)

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