P
Aphel,
I have some experience with FDA inspections in Europe and I think the comments above are all good and helpful.
Two things regarding preparation are key in my opinion for a successful inspection:
1) Refresh auditee training
2) Perform a mock audit
As an FDA inspection is very different from your yearly notified body audits, it is good to inform management and key staff on the differences and expected behavior. As stated before: you don't want your CEO to start present 30 minutes of marketing bla bla.
A mock audit is not only valuable to identify any gaps but should be used to test your backoffice. How soon can you get the required records? How do you track all the requests of the inspector, how do you get the right people in the backroom, how do you communicate with the front room? Do you show (printed) paper files or electronic records? If you have enough money you can hire an ex-FDA inspector for this mock inspection. Besides, they often know most current FDA inspectors and can give you information about their preferences.
If you are interested, I can give you more details about how I normally setup the back room.
Good luck!
I have some experience with FDA inspections in Europe and I think the comments above are all good and helpful.
Two things regarding preparation are key in my opinion for a successful inspection:
1) Refresh auditee training
2) Perform a mock audit
As an FDA inspection is very different from your yearly notified body audits, it is good to inform management and key staff on the differences and expected behavior. As stated before: you don't want your CEO to start present 30 minutes of marketing bla bla.
A mock audit is not only valuable to identify any gaps but should be used to test your backoffice. How soon can you get the required records? How do you track all the requests of the inspector, how do you get the right people in the backroom, how do you communicate with the front room? Do you show (printed) paper files or electronic records? If you have enough money you can hire an ex-FDA inspector for this mock inspection. Besides, they often know most current FDA inspectors and can give you information about their preferences.
If you are interested, I can give you more details about how I normally setup the back room.
Good luck!