Data Integrity - FDA's Latest Thinking

This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.

"That harkens back to the time of the generic drug scandal when there were just flat out substitution of products, actual dry-labbing [fabricating scientific evidence] in laboratory notebooks and wholesale substitution of data and information," Branding said. Agency inspectors are now trained to be looking at inconsistencies or discrepancies that raise questions regarding the validity of records and data, as well as questioning whether preapproval batches are GMP compliant and if unfavorable tests results were recorded.

Areas Covered in the Session:

• What is data integrity
• How it is implemented in your company
• The FDA's position on Data Integrity
• Data Integrity Issues & Warning Letters
• Industry Best Practices for Data Integrity compliance
  • Domestic
  • International
• Data Integrity in Cloud, Virtualization and Big Data
• Future Trends

• CEO
• Regulatory VP
• Quality VPs
• IT VPs
• Regulatory Affairs Professionals
• Quality Managers
• Quality Engineers
• Small Business Owners
• GxP
• Consultants