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.
The 09-10 July 2018 (Level 1) Data Integrity Workshop, the 11-12 July 2018 (Level 2) Data Integrity Governance, including Train-the-Trainer & Advanced Topics Workshop, and the 13 July 2018 (Level 3) Critical Thinking & Advanced Auditing for Data Integrity Workshop will be held will be held at the lovely Hotel Vermont in Burlington, Vermont, www.hotelvt.com, a boutique hotel centrally located in the heart of Burlington, overlooking the beautiful Lake Champlain. A limited number of sleeping rooms have been reserved at a discounted rate for “Green Mountain Quality Assurance” of $179/night; please hurry to reserve by phoning +1 802.651.0080 or +1 865.650.0080 no later than 11 June 2018.