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 honest...

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 m...

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 ...

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 b...

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, whi...

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, adjust...

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...

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 Capston...

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 60h...

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 mo...

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 shi...

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...

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 comp...

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 extrava...

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...