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Data Integrity Workshop - Level 2 - Burlington, VT, U.S.


  • Hotel Vermont 41 Cherry Street Burlington, VT, 05401 United States (map)

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. 

Workshop Venue

The 09-10 July 2018 (Level 1) Data Integrity Workshopthe 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.