Simulation of FDA Inspections
Are you seeking an ex-FDA inspector to perform a simulation of FDA inspections?
If your answer is yes, the quest is over because you’ve reached the right place. AP FDA Consulting began with an ex-FDA inspector of medical device and drug manufacturers, and therefore, simulating inspections for these manufacturers is our specialty.
The most beneficial, inexpensive way to prepare for an FDA inspection is to simulate an FDA inspection. It’s also a strategic way to train your staff to be mentally prepared for such inspections. By tapping into our accumulated experience and expertise, you can identify deficiencies that have prevented you from complying with FDA requirements.
Therefore, to avoid putting your company at risk of being out of compliance, look no farther. Contact us today and let us perform a simulation of FDA inspections.
Our Experience Is Your Advantage
With more than 30 years of experience, we have successfully positioned ourselves to help manufacturers prepare for the inspection. In addition, our ex-FDA investigator can provide you with the latest, most up-to-date guidelines for complying with CFR 21 Section 820. CFR, Code of Federal Regulations, Title 21, is part of the Current Good Manufacturing Practice (CGMP) regulations. Every manufacturer must comply, “customized” to their unique manufacturing process and product. Therefore, duplicating other manufacturers’ CGMP may not be adequate. This is the reason it’s called Current Good Manufacturing Practice.
Our ex-FDA investigator has worked in an official government capacity but is now here to help you. We know what officials are looking for when they come to your manufacturing plant, and we can pass that knowledge on to you to benefit your company.
AP FDA Consulting can perform expert simulations of FDA inspections.
Thus, we will bring our skills and techniques to dive in depth into all aspects of FDA compliance. Finally, we will advise you on detailed sections and areas that require improvements. Please don’t wait. Reach out to us and let us perform a simulation of FDA inspections and assist you with our FDA consulting services.