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 validated.

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 whole life cycle. As the professor had stated, he/she acts a CEO of just that one particular product,…[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 intellectual rights, whereas ensuring protections for decades.

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 close to expiring, the company should must determine new routes to…[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 a magnet to sift through any shaving particulates that would result from the tablet press. I don’t recall the exact…[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 in the acquirement of a job as well. The company would have to spend less time and resources to…[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 required class in technical writing, that would help in the work environment. I was fortunate enough that my…[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 machine will sit as to allow proper filling, negative pressurize room environment to prevent active medicine to contaminate…[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 amazon, or online forums such as reddits. End users can give feedback on improvements for the next iteration of the…[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.

I have also worked at a small start-up, nutraceutical, and was there during the actual QMS setup phase. In order to…[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 in positions at any point much easier. The only draw back to this, when SOPs need to changed, it can have a cascading…[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 to agree on a certain process. Standardization is also critical to ensure everything flows the…[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 amount could find themselves looking for another job. While others think the restrictions are rid…[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 for both parties as they are assigned a specialist to help them settle their case.…[Read more]