Although the example that I will provide is more related to electrical engineering, I hope it helps you understand verification and validation in a better way. The company I used to work for was in ch...

Hello everyone, I hope everything is going well. Dr. Simon mentioned in the lecture that you during the design verification and validation phase, the engineer is supposed to kind of “make up a test.” ...

In the lecture Dr. Simon mentioned that if your device posses a significant risk the FDA might require clinical trials. I know there are other reasons for why a product might require clinical trials ...

This is very interesting. I had never heard of it so thank you for bringing it up. In respect to your question, all biologics fall into the CBER department. The regulation process required for the FDA...

I think that they are very similar in the role developed, with the only difference that a project manager covers any project. For example: he/she could lead and execute the construction of a building ...

Hello everyone, My experience in the Industry is mostly in the Electrical Engineering Industry. As I mentioned in my previous post, I work as a Project Manager Assistant. My undergraduate track here a...

Hello everyone, I have worked in a small Electrical Engineering company that sells all kinds electric products such as motors, transformers, solar and wind power generators. The company has a store wh...

Hello everyone. As Dr. Simon mentioned in the lecture, the 5 areas of emotional intelligence represent a good project manager. However if I had to add other skills to these 5 areas, I would add strong...

Hello everyone, As I was listening to this week's lecture, it called my attention the fact that companies can only give gifts of 100$ to the physicians and those gifts have to be related to health. Ad...

I would never agree with someone using a "verbal agreement" because if you don't have a written contract of what everyone is supposed to do, a lot of problems will arise and lawsuits might take place,...

Dr Simon, At the beginning of the semester, I was not sure if I was going to stay in the class due to having so many courses this semester. But as the lectures started, I understood that this course i...

Very interesting point lamiaa. I believe that it will be more challenging for project managers to work in matrix organizations because they have cross the limits that the departments set and deal with...

I worked in a small project where the owner of the company was the one who chose the team. The most important criteria used was that they needed to be hands on individuals who executed the project as ...

In my previous experience, it was more like functional organization. I used to work in a small business where there was a lot of work for a few employees. However, all the projects were done by the sa...

These costs have a bigger impact in those companies that are just starting and don't have a big budget. Big company have no problem with paying a lot of money for it because they have a big budget. T...