As mentioned above, the primary way to organize task priority is by which tasks need to be completed before the next task can be started. In the case, where two tasks are independent of each other and you have to…   Read more»

For my Senior Capstone project we used Microsoft Project to make a Gantt chart to plan our project. This was a really helpful tool because it helped us keep track of all the tasks and steps in the project. In…   Read more»

I feel that slack must always be a factor that a team manager must take into consideration when planning a project. Vacations and delays are expected to occur throughout the duration of a project, and since they cannot always be…   Read more»

When we did the planning process for my Senior Project we started by breaking up the overall project into smaller portions and then listed all the steps and tasks that would need to be done for each portion. For example,…   Read more»

If I were a team manager I would include a safety net of a few days to a week when I plan the project schedule. I would try to delegate the member’s responsibilities to the rest of the team for…   Read more»

The pros of separating the risk management team from the project management team is that the risk assessment can be done by a party that was not directly involved in the development of the product. This can help provide a…   Read more»

While I agree that the planning is crucial to the project management process, I feel that the execution is equally if not more important. Despite how detailed the planning is, there will always be unforeseen problems that will arise during…   Read more»

It’s very common to have a difficult member on your team. Although this can make the entire project very cumbersome, it is important to remember that you both still have the same project goal. This is why it is important…   Read more»

I believe the best way to handle underperforming team members is to have good communication with them through each step of the project. It is important as team manager to be aware of what stage each member is at in…   Read more»

I agree that the best way to divide the workload is to create separate groups to work on an individual portion of the project. This allows for the sharing of ideas and can aid the members come up with creative…   Read more»

I had to do verification and validation testing for my Senior capstone in my undergrad. Verification is essentially where you test to see if specific requirements have been fulfilled. This is done with the specifications for the design in mind,…   Read more»

In both scenarios, as a team member and as a team leader, I believe that a hands off method is the better management style. However, I do believe that it would be beneficial for the manager to check in with…   Read more»

I have some experience doing design verification since my Senior Capstone for my bachelors followed the 21 CFR 820.30 process. We had requirements and specifications for each aspect of our device. To expand on what previous posts have said, we…   Read more»

I do not think that it is ironic because the FDA was not established just because antifreeze was a component of the elixir, but rather because a large and unregulated amount of the compound was included. There was no way…   Read more»

I would want to work in the product development portion of the regulatory function because they work directly with the team developing the device and help ensure that the device claims meets FDA guidelines. This role seems intrigues me more…   Read more»

I believe the most important responsibility of the FDA is to review and approve prescription, over the counter, and generic drugs. I believe that this is the most important responsibility of the FDA because of how profitable drug development can…   Read more»

@terril_vallikalam  My situation was actually the opposite of yours. In the case of my capstone team, each person had worked with at least one other team member in a class project. Due to this we were aware of how each…   Read more»

@jbarbee  If the initial strategy of conducting a meeting with the team members to discuss their opinions and views to contribute to an overall plan does not work then the I believe the next steps would ultimately fall to the…   Read more»

I believe that one of the most important management skills is the ability to properly plan out the steps for a project. It is crucial for members of a team to deliver their project contributions on time to ensure that…   Read more»