About This Course

Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.

Learn to comply within the expectations of regulatory authorities. This course is designed to provide you with an overview of what is meant by data integrity and how to build a robust data governance system. Regardless of the format, this new system will help to keep your data complete, consistent and accurate throughout the data lifecycle.

Key Learning Objectives

On completion of this pharmaceutical data integrity course, delegates will know and understand:

  • What is meant by data integrity
  • The current EMA, FDA and MHRA expectations for data integrity, and the WHO and PIC/S guidance
  • How to create and implement a data governance system:
    • Documented risk assessments to identify the prioritization of mitigation activities
    • Appropriate technical and organizational controls for all records, paper-based, electronic or hybrid
    • How to handle data integrity issues – consideration of genuine errors and fraudulent activity
    • The importance of company culture in building a robust data governance system

Course Outline

  • Data governance systems
  • Organizational influences on successful data integrity management
  • Quality culture
  • Dealing with data integrity issues found internally
  • Risk management across the data lifecycle
  • Data integrity considerations for outsourced activities
  • Specific data integrity considerations for:
    • Paper-based systems
      • Control of blank forms/templates/records
      • Generation, distribution and control of records
      • Good documentation practice
    • Electronic systems
      • Direct printouts and true copies
      • Qualification and validation of computerized systems
      • Security
      • Audit trails
      • Data capture/entry
      • Data review
    • Hybrid systems

Who Should Attend

This pharmaceutical data integrity course is beneficial to anyone who operates within a pharmaceutical quality system or who conducts audits of pharmaceutical manufacturers or their suppliers.