The thing is that what you may be working on (as covered by an NDA) may not be sufficient to be apply for a patent. You may in fact be needing work or...
The biggest difference between a written and oral contract is that a written contract can easily be defended in court, while an oral one requires addi...
Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that...
It's been my experience that project teams are simply made by allocating personnel from each function that have less responsibilities with other proje...
My work setting seems to fit best as a matrix-type of organization. There are functional departments as well as project teams and project managers. Ho...
The way it was done in my previous job was to use a quality by design matrix. Critical quality attributes (CQAs) were determined based on the design i...
Two other methods are: Hazard Operability Analysis (HAZOP) - Based on a theory that assumes that risk events are caused by deviations from the desig...
I've wondered about this as well, especially because in academic research I've needed to look at ISO standards and I wasn't going to pay for them. I f...
This is an interesting question, which brings another question to mind: would design transfer activities even have begun at phase I clinical studies? ...
I can only speak to my experience, but generally it's been as Roberto pointed out. Nobody really pays much attention to the minutes and they are more ...
If quality by design is used in the development of the product, a simple way to come up with tests for verification/validation is to just use characte...
I disagree. For a smaller company, it is usually more cost effective to outsource manufacturing because they rarely have the infrastructure required f...
Many things can go wrong during transfer. For example, if the design specs heretofore have all been for a product made through a different process and...
It seems that the DHF is superior to the Design Dossier or Tech File in it's thoroughness and documentation and that is why there seems to be a move i...