Presentation material: FDA Data Integrity-CSA Part Two Webinar (Mar 16 2021)

During the webinar, we learnt how CSA can be adapted to benefit your organization and the application of Data Integrity.

Topics Covered:

  • How Data Integrity Requirements Should be Treated?
  • Data Integrity Guidance and its Intent
  • How to establish and maintain Data Integrity?
  • How to Handle Perceived Data Integrity Challenges?
  • FDA’s tips on How Companies can meet Regulatory Requirements
  • How to Utilize Opportunities to Align Regulatorily,Enforcement and Compliance Approaches
  • Applying CSA to Data Integrity Challenges
  • CSA Appendix