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Data Integrity Workshop - Level 2 - Windsor/London, U.K


  • Macdonald Windsor Hotel 23 High Street Windsor United Kingdom (map)
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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.