Learning Objectives:

Upon completing this course participants should:

• Assure your understanding of the fundamental causes of Data Integrity issues
• Be able to identify these key elements
• Understand how cGMP regulations impact Data Integrity issues
• Understanding the various inspection approaches to monitor for Data Integrity
• Learn how to determine the regulatory requirements required to assure Data Integrity
• Understand the consequences of questionable data and how they may lead to seizures, import alerts, etc