Product Introduction is also very important as it follows after Planning and Development. Some of the key aspects in Product Introduction are reviewing project at regular intervals and begin establishing connections to customers. Keeping track of the project during the…   Read more»

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 partner and I came…   Read more»

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 program. As a Project Coordinator, I am…   Read more»

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 make up to $700 per semester…   Read more»

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 verification and validation are where…   Read more»

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. And often times when the project is almost finished but…   Read more»

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…   Read more»

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 produce accurate results. It would be a on…   Read more»

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…   Read more»

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…   Read more»

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 equipment in someway which may…   Read more»

Adding to what Hiren Rana said, not only will the project manager need to allocate more time for R&D. The test protocols may need to revised. This would take more time and causing a delay in the tasks down the…   Read more»

Sharing my research experience, I was doing a computational study on the BCR phili gene. The entire research project was broken down into multiple parts: Computational Data, Analysis, Literature comparison, and finally presenting my findings to a committee in order…   Read more»

I think Verification can occur anytime during a project. I do not have any industry experience but theoretically speaking Verification can occur at any point. It can also occur during the research phase where making a change in your project…   Read more»

In designing a hip stem implant and running finite element analysis on it last semester. After creating the part file which took hours, and applying constraints and loads on the hip stem implant. After running 20 analysis to predict where…   Read more»

Not knowing your budget can limit your team members. For example, when you hire people for a project they work at a specific rate. So if you do not know your budget it can be problematic in getting the team…   Read more»

My opinion on this is, SOPs should not be required during the research phase. The main reason behind this is that during the research phase your project can take multiple phases. There could be second opinions or alternative ideas involved…   Read more»

Agreeing with everyone here, in addition I would say the SOPs should be written so someone with a high school education can read them without any confusion. Also, it varies from project to project. Some projects require a lot of…   Read more»

I do not have any work experience in this field. However, from what we learned so far. I would choose the second option you posted. Reason being is the work instructions step. This is vital in any Quality Management System…   Read more»

As everyone already answered the initial question in full detail. I would like to add why I believe it is important to have post market surveillance. Yes it gives companies feedback and how to better future products or if a…   Read more»