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Data Integrity Workshop - Level 3 - Burlington, VT, U.S.

  • Hotel Vermont 41 Cherry Street Burlington, Vermont United States (map)

This 1-day workshop provides the opportunity to interact and share ideas with other experienced GxP personnel in small-group, hands-on inspection case study exercises as each team applies their data integrity inspection skills in mock inspection scenarios.  Highlights include:

  • Critical Thinking Skill Development Exercises

  • Small Group Mock Inspection Exercises

  • Inspecting Live Computer Systems for Data Integrity Controls

  • Data Analytics Tools for Analyzing Data Exports

  • Pattern Recognition Exercises

  • Interviewing Techniques

  • Flags for Parallel Record-Keeping

  • Recovering Deleted Data

  • Evaluating Data Governance Programs

  • Data Process Maps and Data Life Cycle Assessments

  • Preparing Responses to Data Integrity-Related Health Authority Observations

  • Experience sharing and discussions among experienced auditors: "What has worked best?"

  • More Case Studies

The Level 3 workshop is designed for personnel who have completed the GMQA Level 1 and Level 2 workshops and have a minimum of 5 years of GxP experience.  The Level 3 workshop may be of particular interest to Quality Auditors, as well as personnel responsible for establishing and managing Data Integrity Compliance Programs / CGxP Data Governance Programs, Quality Risk Management; Management Governance and Knowledge Management program teams; personnel responsible for establishing Data Integrity Training Programs; Information Technology, and Computer Validation personnel, as well as personnel in Operational roles preparing for data integrity inspections.

Later Event: August 12
GMP by the Sea