So, you have come to the end of your inspectional process and now you are sitting in your...

Tips to improve your experience by Nigel J Smart PhD During this time of modified practices there...

As the Covid -19 pandemic rages on, there is now a scramble by the governments of the world to...

With a booming level of sales of CBD oil in the dietary supplement field, the question needs to be...

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So now you have a Warning Letter or worse, a Consent Decree and you need a strategy to move...

At a time when we must be efficient to remain competitive, it is important to set the correct...

It is important during an inspection to have a well-oiled strategy that has been honed and...

So, here we are amid a pandemic that the planet hasn’t witnessed the like of for a century! Not...

So, what are some of the things that we need to do to get ready for the next FDA inspection?First...

The FDA will look for entry points into your Quality Management System as a mechanism to highlight...

With the ever-increasing complexity of pharmaceutical supply chains, as more and more companies...