Quality Partners has decades of FDA audit experience. We also have decades of experience managing FDA audits while working in the regulated industry. Several of our training courses present your managers and staff with actual situations faced during FDA audits. Here are several case studies presented during our FDA Readiness course:
Case study #1: Chatty Kathy
During an FDA audit, the investigator is interviewing one of the lab analysts. The conversation develops into a discussion about recent problems with calibration of equipment. The chemist states, “You think that problem was bad, you should have seen the one we had last fall.” She then describes a number of past problems, all of which you are aware..
The information was truthful and the employee was trying to be helpful.
How would you deal with this situation?
Did the chemist do harm or benefit to the company?
How can you prevent this type of communication from reoccurring?
Case study #3: Better late than never?
One day after the FDA investigator has left your firm he calls and asks you for a document that was referenced in his notes but not collected during the inspection.
Do you have to provide the document?
How would you respond?
Case study #2: Is this legal?
The investigator has stated that she has prepared an affidavit for you to sign. You read the affidavit in front of the investigator and it says that you are responsible for certain activities and that you are aware of certain deficiencies in the Quality System. She asks you to sign it.
