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Data Integrity Workshop - Level 1 - La Jolla, CA, U.S.

  • La Valencia Hotel 1132 Prospect Street La Jolla, California United States (map)

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, with a specific focus on electronic data and computerized systems.  Example topics include:

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

  • Data Life Cycle and Data Process Design and Controls

  • Data Integrity Governance Compliance Plans and Accountability Structures

  • Management Governance & Quality Culture

  • Validation for Data Integrity

  • 21 CFR Part 11: Electronic Records, Electronic Signatures

  • EU Annex 11

  • Health Authorities' Data Integrity Guidances

  • Techniques to Identify and Investigate Aberrant Data Patterns

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

  • Risk assessment tools

  • Preparing for FDA inspections of facilities and electronic data

  • 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 CGxP 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.  Participants will also be able to conduct a hands-on inspection of a live computerized system to detect data integrity issues and define appropriate corrective and preventative actions.