The Inspector's Questions

Practice responding to common inspector questions with confidence

Role: Drug Safety Manager

Context: An EMA GVP inspection is underway at your site. The inspector has reviewed documents and now wants to discuss your procedures with you.

Task: Answer the inspector's questions clearly, confidently, and accurately.

Step 1 of 3

Question 1: Day Zero Discrepancy

interview

Inspector: 'I've been reviewing your expedited cases. Case XYZ-2024-0847 shows the event occurred on March 3rd, but Day 0 is recorded as March 5th. There's a 2-day discrepancy. Can you explain this?'

How do you respond?