Good to be Grey? Not really

One of the biggest frustrations when working with any of the regulatory bodies are all of the ‘grey areas’. Seek guidance from them and the usual response is that the “law or regulation states this, we understand that your circumstance doesn’t fit into this...

What does quality cost?

This was a question that came up last week in a meeting. Given that there were both Commercial and Quality people in the meeting it generated some interesting discussion, particularly for me as it is fair to say I have worn both hats simultaneously for much of the...