Data Integrity: FDA, WHO and EMA`s Requirements 2016

Topics

• The key elements
• The fundamental causes of Data Integrity issues
• The various inspection approaches to monitor for Data Integrity
• How the regulations impact Data Integrity issues
• Why Data Integrity that is not reliable hints of a Company being outside of compliance and questions the quality of the product being produced
• Is there a right or wrong way to monitor for Data Integrity
• The consequences of questionable data and how they may lead to seizures, import alerts, etc

Who should Attend

• Regulatory professionals
• Quality professionals
• Manufacturing engineers
• Compliance professionals
• Quality auditors
• Quality engineers
• Microbiology
• Quality Control
• Document control specialists