Simulate FDA Audits
Why simulate FDA audits? Complying with a regulator is among the most common issues many manufacturers face. Nonetheless, maintaining maximum compliance with the Food and Drug Act requires significant effort. Therefore, our specialists represent your best option for practicing or simulating an FDA inspection.
Our FDA consultant to simulate FDA audits
We have decades of professional experience and unmatched capabilities. In addition, our former FDA investigator, working in an official capacity, can relate to the FDA side of issues. Therefore, we will take a closer look at the current status of your company’s quality policies and procedures. After that, we should have a better idea of the state of your compliance with CGMP. Moreover, by scanning through your quality system, we can help you determine potential areas in need of improvement.
We will bring every tool we have to give you the most effective mock FDA inspection. This is what we do, so don’t wait any longer. Ours is the right team of qualified auditors who can help you ensure greater success in actual US FDA audits.
Our FDA consultant will conduct simulations designed to identify any gaps in your quality system, and these findings will play an important role. By selecting our team to simulate FDA audits, you will have a much better idea about the state of your CGMP compliance.
Training Your Quality Team
In addition to mock FDA inspections, we provide GMP or QSR training for your staff. Unfortunately, we cannot prevent the recall of non-conforming products or avoid Form 483 observations during an inspection. However, we can train your staff to minimize these. After simulating FDA audits, we should have a better understanding of which departmental employees can benefit from focused training.
Based on our experience, if your staff is better trained, their performance will be better. In addition, this is the reason 21 CFR specifically mandates employee-training procedures.
So what are you waiting for … a notice from the FDA?