For a project we were working on it was a smaller part of a whole, which was analyzing viral clearance for a legacy product process. At first we did the initial research and looked through historical ...

I have had several instances where I've had to deal with vendors and our project team has had to work on choosing the appropriate vendor. The initial steps in dealing with the situation are setting up...

Similar to Davids's situation I was in the same class and our final project was a novel prosthetic arm. Our proposal was the development of new types of soft robotic structures, especially materials/m...

An example of a combination product would be Stryker's Vitagel Hemostat ( The delivery system for this product is a syringe and the primary mode of providing a therapeutic effect comes from the conte...

An example that I dealt with on a team at work was on a hemostatic agent that we were releasing. The testing that we conducted with the contract lab suggested that there would be potential risk associ...

Although I do not have personal experience with FDA audits. We are always reminded to adhere to the protocols set forth because they are in place as safeguards for if/when audits do occur. Employees a...

For a animal trial study I worked on we had a cost variance associated with the study, and did end up going over budget as our cost variance was negative. Our earned value on the project was estimated...

Logging work is definitely an important aspect of research and development for any company. When I started working for my current company about 2 years ago logged research was essential in helping me ...

To extend on tn58's response, a project manager also faces a similar issue with information, not only for budgets but also for product information. It has been a repeated theme in Dr. Simon's lectures...

The best course of action for all those questions is establishing proper communication with all team members. While acquiring team members it is the project manager's responsibility to organize a roug...

This is my first course with Dr. Simon and since I work in industry I had experience in most of the topics that we are learning. The greatest benefit this course provides for me is the thought process...

Currently at my company we are working on a project that is international, as we must communicate with Brazil, India, and Austria. The key hurdle with project management is the time difference within ...

Missing a milestone is usually more than a minor hurdle within industry. For a project missing milestones as indicated in your post would waste company financial resources. However, this is not the ex...

During a project that I was working on our team missed a milestone for our execution of animal trials. We had gone through the protocols for conducting the trial, however there was an error in the pap...

During the planning phase of a project estimations play a critical role. For medical device projects the cost estimation is not always straightforward as discussed in the lectures. Another estimation ...