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Data Integrity Workshop - Level 1 - Dublin, Ireland


  • The Gibson Hotel Eastpoint St Dublin Ireland (map)

This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to assuring Data Integrity, with a specific focus on Electronic Data and Computerized Systems and compliance with 21 CFR Part 11, including:

  • Data Integrity -- Risk-Based Approach to Preventing & Detecting
  • Data Life Cycle Design and Controls
  • Validation for Data Integrity
  • 21 CFR Part 11: Electronic Records, Electronic Signatures
  • EU Annex 11
  • CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances
  • Data Integrity Compliance Plans and Accountability Structures
  • Techniques to Identify and Investigate Aberrant Data Patterns
  • Reviewing electronic data and metadata--such as audit trails
  • Risk assessment tools
  • Case study of hands-on live system audit to detect data integrity issues
  • And much more