It’s really hard to have a animal study fully represent the potential effects of a drug/medical device within a human. There are so many variables within a human that can drastically effect how the drug/medical device will respond or more…   Read more»

As someone who is starting there career within the medical device industry and applying what was learned in class, I felt that applying my knowledge from class concurrently with the application aspect helps me to fully understand what goes on…   Read more»

As someone who has worked within the medical device industry and consumer, these simulation have reminded me of the type of typical day to day problems/issues that could potentially occur. Their could be multiple approaches to solve these simulations, which…   Read more»

I have seen it myself sometimes the area disconnect, when I worked in consumer, I saw the constant push on the release of product from upper management, but never the recognition of a great job. I have seen that contracts…   Read more»

Great question, but I am quite sure where ideally I would like to end up. Ideally, I would like to work as an engineer for a few years… gain experience within the field and develop my career. Ideally after maximizing…   Read more»

I know a few people that had a fear of feeling ” too comfortable” at work, sometimes you adjust to a certain rhythym and just conform, as a result they move around to another position. Currently, I am transitioning from…   Read more»

I would really enjoy going into R&D, but not within the clinical research area. I feel that this aspect within industry is probably one of the toughest. I attached a link to a website that talks about the pros and…   Read more»

Well in my opinion it depends, whether its as a result of the trial itself or the manufacturer of the drug. As the comments mentioned above, there could be an investigation on the drug, which find components to be not…   Read more»

Great topic, and I read an article with regards to shifting clinicial trials to third world countries because of the cost and the not as stringent regulations in other countries.
http://theconversation.com/ethics-vs-economics-the-cost-of-outsourcing-clinical-trials-to-developing-countries-43246

My biggest motivation at work is the impact that the product that I work see manufacture has on the patients. In addition, my ambitions come from my family and friends that inspire me to go a step further than what…   Read more»

The best method to motivate my team members, if i was a project manager, would be to show the influence the product being produced has on the users. For example, show the logistics on how the product is growing and…   Read more»

As someone who works within the medical device industry, I am kind of surprised how “meaningful work/ make a difference” is listed so low. I know the engineers that I have spoken mostly stated that they want to make a…   Read more»

I don’t have direct experience within procurement, but I know that procurement is very contract oriented and once these suppliers are approved into the company, the company essentially has rights to be purchased from the company. In addition, approved vendor…   Read more»

During summer internship, my main task was to reform out of a particular raw material. My internship consisted of several parts, which also incorporated a potential introduction to a new process change, if given enough time to complete the reform….   Read more»

From my experience, I am split between two departments, but I directly report to one. When the department that I am hired doesn’t have a major project in the works, I am sent to the quality department to help them…   Read more»

As Viraj mentioned, the CAPA itself is used to find the route cause of non-conformity and a method to address the NC, while creating a way to prevent it from happening again. During the CAPA execution, documentation may change such…   Read more»

We are actually doing an internal Audit either next week or the following. The biggest advantage about the internal audit is that potential issues can be addressed early before the outside auditor arrives. A corrective action can be initiated to…   Read more»

I have personally dealt with a non-conformity, on a material that we manufacture, the material failed one of the critical inspection areas within Quality assurance, which opened an investigation to find the route cause of what caused the failure within…   Read more»

Ambiguity of GMPs for start up companies are completing understandable, I believe that is is a learning curve for these types of companies, because their product is being initialized in production and there are no pre-existing GMPs nor standards. As…   Read more»

In a No GMP aspect, I use to work for a company that did not utilize GMPs, and the process to upscale a potential product from lab to production became difficult at times, because methods that could replicate the lab…   Read more»