FDA inspection

Preparation of a GCP FDA Inspection

We were asked for help in preparing a GCP inspection by the FDA. The project lasted 1.5 months.

This is how we did it:

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

Outcome

The inspection was a success not only for the result, but for the good collaboration between the client and Clina Research.