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.