Exam 2 Flashcards
1
Q
_____ ensures that trial related obligations and acceptability of resultan clinical data is in support of a new drug approval.
A
Inspection
2
Q
In a _____ the inspector is an employee of the company who work for an active clinical quality assurance
A
Audit
3
Q
FDA form 482 is
A
Notice of Inspection
4
Q
After the inspection, the written response of form 483 should be sent to FDA in ________days
A
15 days
5
Q
During the inspection, you can make a copy of the inspector’s badge
True or false
A
False
6
Q
The mock FDA auditor review the policy for retaining records and products control at the facilities on a day _______?
A
Day 2
7
Q
What is a way to explain and correct unexpected departures from the protocol?
A
Note to File
