Dear all,
Few days ago the company I am working for, was informed by the FDA, that we will have an inspection in March next year.
Our quality system is bulid up according to 21 CFR Part 820 (cGMP) for the last six years. We develop and manufacture medical devices of class 1 and one medical device of class 2 in the USA.
This will be our first FDA inspection (unfortunately it will not be a "for cause inspection"), but we (especially my person) are a little bit nervous about that...
Do you have any good or practical advice for me, how to cope with an inspection in a good way, do you have some hints for preparation, do you know a certain code of conduct regarding inspections or do you have any other guesses derived from your experiences with inspections?
Thank you very very much in advance for your suppoert.
Best regards,
Aphel
Few days ago the company I am working for, was informed by the FDA, that we will have an inspection in March next year.
Our quality system is bulid up according to 21 CFR Part 820 (cGMP) for the last six years. We develop and manufacture medical devices of class 1 and one medical device of class 2 in the USA.
This will be our first FDA inspection (unfortunately it will not be a "for cause inspection"), but we (especially my person) are a little bit nervous about that...
Do you have any good or practical advice for me, how to cope with an inspection in a good way, do you have some hints for preparation, do you know a certain code of conduct regarding inspections or do you have any other guesses derived from your experiences with inspections?
Thank you very very much in advance for your suppoert.
Best regards,
Aphel