Data Integrity - Moving Beyond QMS to Achieve Compliance

The FDA has increasingly observed cGMP violations involving data integrity during inspections. The purpose of the data integrity guidance is to help manufacturers have the tools and systems in place to prevent adulterated products from entering the U.S. marketplace.

What are you doing to ensure the next inspection does not result in a 483 related to data integrity?

In this webinar, Kevin Bogert of Azimuth Compliance Consulting will talk about:

• What is data integrity?
• What are the top 5 data integrity issues?
• Why has the industry taken so long to address data integrity?
• How we see the FDA moving the industry forward to address the issue.
• What is the path forward?