While having a common communication management plan will save time, I believe it needs to be altered depending on the project. If the plan doesn't hel...

The WBS is a crucial part of the scope management process, no matter how small the project may be. It is responsible for breaking down all the tasks, ...

Specifications should be broader during the beginning of design control, but should narrow down during the later stages. The project team can also ref...

I believe it depends on how negative the SV is, and how close the team is to completing the project. If a negative SV was calculated closer to the beg...

The project manager should discuss the amount of work and timeframe required for the project with potential members to make sure they can fully commit...

One main solution to staying on or ahead of schedule (positive schedule variance) is adequate and thorough planning during the initiating and planning...

I believe that one of the most important aspects of the monitoring and controlling phase is the design review meeting. Any additional changes, metrics...

While I do not have any industry experience in design review meetings, I think it is crucial to finish the previous step before moving on to the next....

The FDA is strict on ensuring all guidelines are met when audits are conducted. Works logs are one of the documents auditors must review and reference...

Since we are already at the validation phase, I would try to fix the issue with the primary vendor first. I would consult with the primary vendor abou...

I would also follow the ISO requirements and guidelines regardless of enforcement. I feel that developing a medical device that causes users harm duri...

Design validation is crucial, especially if verification fails during the executing phase. It is important to confirm that each numbered input meets t...

Delays are bound to happen, but steps can be taken ahead of time to minimize the magnitude of them. In Dr. Simon's lecture, he mentioned building a sh...

With a deadline fast approaching, it is important to set a strict deadline for the team to follow. As project manager, I would makes sure to designate...

Project managers hold an important role in encouraging group communication, overseeing any disputes, and setting a feasible timeline for each project....