Prepare For FDA Inspections

How to prepare for FDA inspections is the most common question asked by many drug and medical device companies. Fortunately, one of the most effective tools is mock FDA inspections. The world’s largest medical device and drug manufacturers maintain the highest possible compliance with the FDA. And the reason for that is they understand how critically important compliance is!

In addition, process validation is an area many manufacturers struggle with. Our AP FDA Consultant is an expert in this area and can help you prepare for FDA inspections. From the company’s quality system manual to its manufacturing operations, we can review everything before an FDA inspection. That’s precisely why you require our professional services to prepare. Our mock FDA inspections will also let you train your staff and give them experience with FDA inspections and what they should expect.

Our Consultant’s Qualifications

Not only do we have 30 years of unmatched experience but we’re known for our skills and expertise. If our experience is not enough, our FDA consultant has received the following certifications from the FDA.

  1. Performance Auditor Certification in 2003
  2. Investigator Certification in 1997

We will not hesitate to use our knowledge to prepare you and your team for an FDA inspection of your manufacturing facilities. By choosing our mock inspections, you can close any gaps in your quality system. Let us help you with what we do best.

A Preventive Measure: Prepare for FDA Inspections

Again, our FDA consultant will follow the latest compliance guidelines. Finally, our mission is to bring our clients into the best-possible compliance with FDA laws and regulations. We will not promise that you will not receive a Form 483 or any observations. Our duty as consultants cannot provide that. However, we can help you to identify any areas of improvement.

As such, let us help your staff get ready for an FDA audit. Practice, practice, practice—and be ready when FDA knocks on your door. Remember, fixing an observation is far more resourceful than preventing one. You’ve likely heard the old adage “An ounce of prevention is worth a pound of cure.” It’s true here as well. For example, preventive maintenance on a vehicle is far less expensive than repairing it after a breakdown, so don’t risk a costly breakdown in your quality control system!

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