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Workshop - Level 2 - Basking Ridge, NJ


  • Olde Mill Inn 225 U.S. 202 Basking Ridge, NJ, 07920 United States (map)
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Data Integrity Workshop Level 2 - New Jersey (14-15 November 2018)
1,600.00

All pricing is per person.

See information below about government employee and group rate discounts.

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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. 

Earlier Event: November 12
Workshop - Level 1 - Basking Ridge, NJ
Later Event: November 16
Workshop - Level 3 - Basking Ridge, NJ