This 2-day workshop builds upon the materials covered in the Level 1 “Data Integrity Assurance” workshop and provides more in-depth material, advanced topic discussions, additional case studies, and tools and discussions to build an effective data integrity governance program, including:
- Management Governance & Quality Culture that Fosters Data Integrity Assurance and Innovation
- Quality Risk Management and Risk-Based Data Integrity Governance Plans
- The Potential Power and Pitfalls of Metrics
- Considerations for a CGxP "Data Science" Program
- Data Process Mapping & Aligning "Data Life Cycle" with QbD and QRM across the Product Life Cycle
- Organizational Roles and Responsibilities
- Integrating Ethics into CGxP Compliance and Quality Systems
- Incentivizing Data Integrity and Operational Excellence
- Train-the-Trainer: Developing and Implementing a Data Integrity Training Program
- "Critical Thinking" Skills Development Exercises for Quality Auditors
- Integrating Data Integrity into Supplier Management: Quality Agreements and Data Monitoring
- Advanced Computing Highlights--Hybrid Validation Models & Cloud Systems
- Experience sharing and discussions among experienced data integrity compliance teams: "What has worked best?"
- More Case Studies
The Level 2 workshop is designed for personnel who have completed the GMQA Level 1 workshop and are interested in more in-depth coverage of the subject material, including more applied learnings through case studies and small group activities. The Level 2 workshop may be of particular interest to those in the following roles: Senior Quality and Management; those establishing and managing Data Integrity Governance Programs, Quality Auditors and Health Authorities; 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.