One of my graduate courses I took at NJIT, our final project was to make a product which isn't on the market and sell the product to your classmates (who were investors, private companies etc). My pa...

Keeping a log for my current positions is critical. Each meeting, each dollar spent, each appointment, and summary of the nature of the appointments must be submitted to the Director of the EOP progra...

I currently work as a Project Coordinator for NJIT in which I am coordinating an entire project from training to payroll, to dealing with students and tutors. Initially, it was planned each tutor can ...

As Betty explained the tasks needed to be performed by the PM to obtain accurate assessment of quality assurance of the project. To add to the next step, I would say that executing process, design ver...

Agreeing with Betty, another challenge a project manager faces is budget information. Often times, budget information is not distributed to project managers and they are unable to time their projects....

First of, I would talk to the individual team member to make sure everything is going well. As a project manager, it is your duty to make sure each member of the team is in the right mind when coming ...

In my opinion, it would depend on the company. Original validation would expire because changes are made within equipment and those changes need to be validated to assure that the equipment will produ...

I wanted to ask everyone taking this course, how much has this course helped you? Has your understanding of how companies follow and operate under FDA, EU, and other regulations enhanced? I personall...

Looking at this week's simulation, if you were the customer Arugalo Medical how would you modify your timeline if the component you need from a vendor will be delayed for an unknown time period. Sinc...

Hi Guys, So I know we all have been posting discussion questions regarding simulations and all the lectures each week. However, I wanted to get your input on what you think so far about this course? ...

I'm not sure exactly what your question is asking. But in my personal opinion I do not think missing a milestone is a link to future success for a company in the long run. For example, when you miss a...

If I was a project manager for this week's simulation in a real life situation. I would get in contact with everyone from day 1 so there is no falling behind. I would make a WBS and assign parts of th...

I do not think the processes have to be revalidated because of multiple locations. However, I will add that the quality team may have argued this if they saw that each location would impact the equipm...

According to the lectures, Process Validation according to the FDA is defined as "results of a process cannot be fully verified by subsequent inspection and test." And process validation according t...

As Dr. Simon mentioned in the lecture on validate or not to validate. As he pointed out, that the best approach is to validate to reduce any future complaints or issues that may cause your device or p...