As DR. Simon stated the old proverb “ if you fail to plan, plan to fail”. This means including risk management helps for a company not to fail suddenly. If a company never considered risk management t...

The scope is the process of developing a detailed description of the project and product. The inputs are projected charter, requirements documentation, and organizational process assists. The project ...

With M&C there is the process of tracking, reviewing, and regulating the progress to meet the performance objectives defined in the project management plan. Capstone is a great way to learn what p...

I agree with you ks629. The Project Management Process Groups are all valid processes for the different management groups. What is important as Dr. Simon said is the Project Communications Management ...

I do not work in an industry, however, I currently am taking Capstone which I consider the class to be a Matrix set-up. The reason for this, is I report to both the functional manager i.e.( Dr.Schesse...

From reading all the response I did some research and found that there are 6 categories involved with Risk Management. They are Risk Identification, Risk Responsibilities, Risk Assessment, Risk Respon...

I do not have experience with packaging but have heard from John Crombie the details associated with the packing. Early evaluation of product-packaging compatibility helps to detect design of manufact...

In the purpose section of the QSPT (quality system plan template) the question of “Why?” must be answered. The purpose of this document is to ensure a quality system plan is in compliance with new and...

I agree with as934 and additional to both voices, I want to examine the internal and external stakeholders briefly. We know employees can be considered stakeholders in a company. The first thought I h...

This is a timely question to ask! I am in Capstone which is an academic setting however, the fundamentals are what is being taught due to time constraints. One fundamental concept is the customer need...

This medical device is both a device and drug, therefore it is considered a combination product as stated by regulation. The PMOA is too gather a signal of a patient who took their pill or not and mon...

A few possible solutions if it were ideal situations. First, there should be a regulatory affairs individual from the company that is assisting or consulting with 30%- 50% of the project. This allows ...

I say yes it should be regulated by FDA as a Class 1 device at maximum. The reason I state this because when I was taking a class in Medicine and Literature a common theme was commercialization. With ...

Dr. Simon has a diagram that has from left too right as follows: strategy -> tactics -> programs -> projects begin last. In the video, he spoke of this hierarchy of business logic. My dad wo...

Dr.Simon has mentioned how for Master students those of which have not taken design classes before unless you have been from NJIT as an undergrad, you know BME 383 (Mantilla) gets you prepared to do y...