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
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.