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 internal training program to assure data integrity and inspection-readiness, including:
Management Governance & Quality Culture that Fosters Data Integrity Assurance and Innovation
Quality Risk Management and Risk-Based Data Integrity Plans
The Potential Power and Pitfalls of Metrics
Building a GxP Data Governance and "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 GxP 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
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 Compliance Programs / GxP Data 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.