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. Workin...

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...

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 industr...

Like many prior posts have said, working backwards is an extremely useful strategy to help set deadlines and time lines. In addition to working backwa...

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, therefor...

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 impor...

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 proj...

Some other important people to include in design review meeting should include stakeholders who overall have the final say in the approval of the prod...

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 ...

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 wha...

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 t...

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 ...

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 ever...

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 ...

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