Name
Why Investigate? 
Date & Time
Tuesday, October 12, 2021, 11:10 AM - 12:15 PM
James Vesper
Description
  • Activity: Reasons for and benefits of investigations
  • Patient safety
  • Quality reasons
  • Business reasons
  • Investigations, Q10, and process understanding
  • Regulatory expectations
  • Regulatory agency findings, FDA observations, and Warning Letters