A specific scenario that had a hazard in a hazardous situation with a specific harm that I have been a part of was during my summer internship. Working on a job site with multiple construction vehicle...

I think that an argument can be made that the manufacturing process requires the most attention out of the three listed stages. Risk management during the product, the product designing, and the manuf...

I would have to agree, I think safety is one of the biggest risks that could potentially cause a product to be cancelled in the medical device industry. The second leading reason for a project to be c...

Like many prior posts have said, working backwards is an extremely useful strategy to help set deadlines and time lines. In addition to working backwards, one must identify their critical path as well...

I assume that a company that encourages neglect of any issues that create more time, money, or effort would not be a very successful company, therefore, would not be much of a company for long. As a v...

As the prior responses have given great insight on what to do if they were a validation engineer in that situation I would like to point out the importance of communication. Each of the prior comments...

Although I do not have industry experience I would say I was taught a good lesson by a professor in my senior capstone project. After getting our project and our customer needs, one of my group mates ...

Some other important people to include in design review meeting should include stakeholders who overall have the final say in the approval of the product. Aside from the people who are directly workin...

After listening to Dr. Simon's lectures this week I can think back and point to a time where I performed validation and verification tests. Last year in my senior capstone class we had to perform both...

A clinical study I was interested in after this weeks lectures is a double-blind study. A double-blind study is when both the doctor is unaware of what the patient is receiving, whether it is actual t...

This is a topic I too thought about after listening to this weeks lectures. What is the point of not letting the doctor know what patient is getting the drug and what patients are getting the placebo....

I am slightly confused on the question being posed. My confusion lies in your definition of "first round of 'real' patients" to be using the new drug or device. When saying first round of real patient...

Many commercials aired during the Super Bowl catch the eyes of the many viewers glued to their televisions for the most viewed broadcast each and every year. Advertisements for Doritos, Budweiser, and...

In order to have a successful marketing strategy all Four P's need to be addressed thoroughly, but in this day and age I think that promotion is most important to a successful marketing strategy. Alth...

Market forecasting methods can be categorized as three general types which consist of qualitative techniques, time series analysis and projection, and causal models. As time series analysis was discus...