How to Prepare for an FDA Inspection
Are you ready for a random audit by the FDA? If you are lucky, you might only have a few weeks or even days to get ready for a visit from the FDA. When this happens, your quality system should be well maintained and compliant with 21 CFR Part 820. But, there are things you can do to ensure your FDA inspection goes smoothly. In this video, we discuss what to do (and what not to do) before, during, and after an FDA audit, including:
- what to do immediately after the audit is scheduled
- how to prepare your facility for the inspector
- who should interact with the inspector
- when to prepare and present documentation
- expert tips and tricks for a successful audit
Learn all this and much more in this 4-minute video.
Questions? Request more information from our specialists
CONTACT USRelated
-
Latest FDA expectations for conducting human factors validation tests of combination products
FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its published guidance documents.
read more -
FDA and Medical Device Emergency Use Authorization (EUA)
In January 2017, FDA issued a guidance document regarding issuance of EUAs during declared public health emergencies. This guidance provides genera
read more