FDA INSPECTION

We were asked for help in preparing a GCP inspection by the FDA.

The project lasted 1.5 months.

Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.

This is how we did it:

  • Defined the strategy
  • Carried out several audits
  • Defined the answers to the gaps detected during 
the audits
  • Improved the quality system of the department according to the audit results
  • Weekly meetings with the client
  • Preparation and coordination the “back-room” before and during the inspection days