I’ve also been at a company, where they would do internal audits, but would bring in auditors from another location as to make it seem it was an external audit. It proved to better results, and honesty from the workers.

That is a great response gh56, but I disagree with using less expensive methods to produce, for they would be out of spec. This could lead to complete decline of the company. The product must always meet specs established and…   Read more»

gh56, I think you are confused between the roles of a project manager and a product manager. Project manager, works towards attaining a clear set of objectives. Whereas a product manager will oversee every aspect of the product throughout it…   Read more»

A project can be killed from my understanding for many reasons, but the most common are lack of resources due to expenses from other divisions, and most definitely if competitors come to market with better product beforehand, also acquiring all…   Read more»

Post-Launch Product Management: Monitoring the product maturity/decline must heavily be examined to see if the product was still consistently selling, or going through a very slow maturity period, while at the same time, the product’s intellectual properties and trademarks were…   Read more»

I have also had the experience of a product batch recall. A customer had complained about metal shavings being in his rx bottle. The company right away had recalled all bottles from that batch, adjusted the packaging line, to have…   Read more»

Having working in industry, this course and others taught by Dr. Simon are definitely inline with what one would experience in the industry. Definitely a valuable set of courses to take within the BME department. Knowing the process, definitely helps…   Read more»

Having completed my undergrad at NJIT, the only place we experience forms of technical writing was doing lab reports for various classes, but the documentations you’re referring to was only in Capstone. I do agree that there should be a…   Read more»

I agree with Fady. The IQ for all four would be along the lines of requirements and environment upon which the equipment will be installed. Such as the electrical outputs (120v 60hz or 3phase 240v 60hz), level bench where the…   Read more»

Post Market Surveillance is obvious in instances of failure, as many have stated, FDA has guidelines on how to go about it. But I think even participation factor from marketing end, where one would monitor just feedback on lets say…   Read more»

Fady, I have worked in the past at a fairly large pharma, which had a very thorough QMS system. Advantage of this, is that everything is kind of well characterized, drawback, a lot of paperwork to shift through during training….   Read more»

I agree with Fady, if SOPs are not established during research, how can one ensure repeatability. I feel one can never have enough SOPs, if each and every operation of the business/research could have an SOP, it would make filling…   Read more»

I agree with Adrian that processes are most important during collaboration. One company may utilize the waterfall method of managing projects while another may use agile. It should be up to the company organizing the collaboration to get each company…   Read more»

Roberto, I believe the restrictions are in place for a reason. Imagine the corruption that could happen if the restriction was lifted. Staff would try to buy their doctor’s attention through extravagant gifts and those who don’t gift the right…   Read more»

Collaborative law is another form of alternative dispute resolution. This resolution relates to resolution between married couples who have elected to separate or divorce and avoid going to court for a settlement. The process of collaborative law is cost effective…   Read more»

Although it may sound easy to recommend an agreement be written versus oral, sometimes time does not allow this to happen and does not allow every agreed upon aspect included in the contract. For instance, when a quick decision needs…   Read more»

In response to the first post, I believe it is better for teams to work with people who are knowledgeable in their department roles. I would avoid assigning people to teams who I know have a bad history together. In…   Read more»

I have to disagree with the first post that organizational culture plays a significant role in the creation of work environment, ethics, and the view of authority. I believe the best teams can be established however; without proper leadership and…   Read more»

Several factors impact organizational performance such as culture, motivation, decision making, and change management. Each of these factors impact organizational behavior differently. I would say one of the most impactful factors is change management. People hate change and when you…   Read more»

I agree that risk management is a “checkbox” activity to some companies. Just like quality control and quality assurance, risk management is important to producing a safe product built of high quality. I believe there is a point where a…   Read more»