If I was a project manager tasked with dealing with changing personnel resources, the first step I would take is to consult the original project timeline, using the software that the company uses. Then, I would assess the impact that…   Read more»

This week, I was in Group 3 for the first simulation. When deciding how to change the procedure for the verification test, there was two things that I noticed were different compared to face to face. The first thing I…   Read more»

For the products that seem to not have a decline, I think that this is because each product has its own length for each of the different phases. For example, a product that seems to have no Decline phase might…   Read more»

Of the three organizational structures which we went over, I would favor the project-based structure because of the way communication and management are done. If I was working on a project, I would like to know every person working on…   Read more»

One of the FDA’s purposes is to ensure the safety and efficacy of medicine. This includes when the product is already on the market. One of the issues of a product on the market that needs to be faced is…   Read more»

From the perspective of a project team member, I can understand how cancelling a project can seem wasteful. In my previous posts I have discussed how initiating a project can be the hardest step of a project. To abandon a…   Read more»

In the future, I do see there being a globalization of regulatory procedures. As for whether this would be a beneficial or not, I think it will because of how it will make medical devices globally available. This is because…   Read more»

There are multiple skills that a project manager needs to succeed, but I think that the most important of these is being able to adapt to unforeseen problems. Almost all projects do not go exactly as planned and there are…   Read more»

In my opinion how Project Management differs in different industries are the which steps need to be completed and the order in which they are done. This is because for each industry the technology is different and the goals (customer…   Read more»

Looking up the definition of validation and verification, the FDA describes validation as proving that “specifications conform with user needs and intended use(s).” and verification as proving that “design output meets design input.” (Source: https://www.fda.gov/media/116762/download) My understanding of this is…   Read more»

First off, I will agree with the view that colleges emphasize on technical knowledge over interpersonal skills. The best example of this is the emphasis on tests where your ability to memorize facts is more important than your communication skills….   Read more»

From my experience, the first step of a project is the hardest because it is the most open-ended. By this I mean that the amount of options that you must choose from is the greatest and among those choices it…   Read more»