Simulate FDA Inspections
If you’re an executive of a quality department for a medical device, in-vitro diagnostic (IVD), or drug company, don’t forget to simulate FDA inspections. It’s part of the Code of Federal Regulations CFR, Part 21 Section 820. It’s also known as Current Good Manufacturing Practice (CGMP) or Quality System Inspection Technique (QSIT) for medical device companies. US FDA adopted QSR in 1997 to help medical device manufacturers comply with 21 CFR 820.
Again, it’s essential to be in compliance with US FDA laws and regulations. The Federal Food, Drug, and Cosmetic Act gives the FDA power to monitor the safety of food, drugs, medical devices, and cosmetics.
For some, this Act is a challenging and complex US law. It governs your products by examining your company’s quality policies and practices. That’s why you will need to simulate FDA inspections today.
The Right Tools & Skills
AP FDA Consulting has the right tools and skills to simulate an effective inspection. We provide unrivaled capabilities, and we continually catering to our clients with the best FDA consultancy for more than 30 years. How? We are ex-FDA inspectors who have served in the US FDA for many years.
Make the most of simulated FDA inspections. Our former FDA investigator will follow the latest US FDA inspection guidelines, such as QSR and CGMP. In this way, we can look at your company’s current compliance and provide you with solutions to any deficiencies that are identified.
It’s time to simulate FDA inspections whether your company is a small or large medical device or pharmaceutical manufacturer.
Today is the perfect time, not tomorrow. Don’t wait until you get a notification of an FDA inspection to schedule your mock FDA inspection. Bringing non-conforming products into compliance is not a matter to be taken lightly—it takes time!