I'd like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company's pol...

When I enrolled as this class (which I did as an elective course), I was expecting to learn more about the technical details of the development of dif...

As Juan mentioned, it was pretty easy to dig up an example of a kickback allegation that occured within the pharmaceutical/medical/device industries. ...

I 100% agree that there should be a good balance of comfort & structure in an organization. I've worked in departments on both ends of that spect...

I work in a matrix organization and I definitely think I prefer working in that environment. At my company, there are distinct departments within the...

I agree with what many others have mentioned so far, that most likely managers do not directly pick their project teams. In that case, as you mention...

As a few others have mentioned, technical transfer activities are not completed until a company has fully developed the medical device/drug/combinatio...

As Murad and others have mentioned, meeting minutes are crucial for capturing meetings and holding meeting attendees responsible for decisions and act...

I think that even though Gantt charts are meant to document all of the related activities for a project, I think overall flexibility is key to deliver...

I think the DHF mindset of continuously documenting the "whole story" is more beneficial than the EU approach, where the design is evaluated at a sing...

I agree with you, John. As others have mentioned, companies that have developed legacy products must have some level of documentation on the design a...

Poor planning can definitely lead to a lack of proper design controls and therefore a medical device lacking in quality, as others have mentioned. As...