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Data Integrity Workshop - Level 1 - New Jersey

  • Olde Mill Inn 225 U.S. 202 Basking Ridge, NJ, 07920 United States (map)
Data Integrity Workshop Level 1 - New Jersey (18-19 November 2019)

All pricing is per person.

See information below about government employee and group rate discounts.

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This 2-day workshop provides comprehensive and highly interactive training in current regulatory expectations and industry approaches to ensuring Data Integrity and compliance with 21 CFR Part 11, including:

  • Data Integrity -- Risk-Based Approach to Preventing & Detecting

  • Data Life Cycle Design and Controls

  • Validation for Data Integrity

  • 21 CFR Part 11: Electronic Records, Electronic Signatures

  • EU Annex 11

  • CGXP Requirements for Data Integrity, including Current Health Authority Data Integrity Guidances

  • Data Integrity Compliance Plans and Accountability Structures

  • Techniques to Identify and Investigate Aberrant Data Patterns

  • Reviewing electronic data and metadata--such as audit trails

  • Risk assessment tools

  • Case study of hands-on live system audit to detect data integrity issues

  • And much more

The Level 1 workshop is designed for personnel responsible for data integrity (i.e., those who create, review and approve data in any GxP Operational role)—as well as novice and advanced Quality & Compliance auditors, Health Authorities, System Users, IT professionals, CSV and Engineering, Management, and more. Participants will have the opportunity to discuss recent industry standards, regulations and guidances and current regulatory expectations, case studies, audit and inspection approaches, assessment tools, and FDA 483s and warning letters.  Attendees will also be able to participate in a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.