What kind of documents would you not want an FDA inspector see? Especially since it seems the FDA has a way to be able to access most documents anyways.
Some people try to hide things from inspectors, but that strategy is usually counter-productive. FDA inspectors are trained to look for companies that are trying to conceal things from them. Usually, the best approach is to share information with inspectors to show that you want to do the right thing and you don't have anything to hide. We also have a webinar and work instruction explaining how to handle FDA inspections: medicaldeviceacademy.com/fda-inspection-webinar/
Have you previously covered what the major differences between the QSR and the QMSR are?
Yes, we conducted a webinar on this topic in February: medicaldeviceacademy.com/21-cfr-820/
What kind of documents would you not want an FDA inspector see? Especially since it seems the FDA has a way to be able to access most documents anyways.
Some people try to hide things from inspectors, but that strategy is usually counter-productive. FDA inspectors are trained to look for companies that are trying to conceal things from them. Usually, the best approach is to share information with inspectors to show that you want to do the right thing and you don't have anything to hide. We also have a webinar and work instruction explaining how to handle FDA inspections: medicaldeviceacademy.com/fda-inspection-webinar/