Hi All, Verification and validation of a process includes making sure that process and all aspects of it are meeting the correct specifications. As ...

Hi All, I would say that the school of thought that appeals to me most is that the DHF is not a living document. As small processes change over time...

Hi All, I was thinking of one way that getting a medical device approved in the EU may be more difficult than in the USA and only thought of one: It...

Hi All, I would agree that devices would be easier to get approved in the EU for a number of reasons. The main reason being that the classification i...

Hi Fady and Luisa, I would agree that it is a difficult measurement to simply say that every time a certain number. However I would agree with Luisa...

Hi All, I currently work in the pharmaceutical industry assisting pharmaceutical companies to outsource their pre-clinical research. I have also loo...

Hi All, Thank you very much for the very interesting topic. I would agree that the restrictions in theory seem to be very strict. However I would ag...

Hi All, As the previous posted mentioned a written contract is greatly needed if any piece of the matter needs to be protected from a legal point of...

Hi All, I believe that this was a very interesting course. As others previously mentioned, I believed that it would be a course that would involve m...

Hi All, I would agree that all who posted that stated a Matrix organization would be ideal. This is due to the fact that a project based organizatio...

Hi All, I would say that the best type of organization would depend on the specific company, but I would consider starting as a matrix organization....

Hi All, Currently I work for a Matrix Organization. While I work currently as a Functional Manager because we are a start-up we work on many other s...

Hi All, At my company we have a similar setup as was mentioned previously: 1- Documentation Reviews 2- Information Gathering Techniques like Brainst...