The most appropriate time to conduct design verification is once all of the design inputs have been specified within the document known as the verification protocol. This requires one to know their p...

I currently work in manufacturing/production at a cell-research company where I process autologous cell-therapy products that is in its clinical phase with the hopes of becoming marketed. The most im...

As we learned in lecture, all projects have a life cycle that dictates how smoothly the design process is going to flow, which in turn determines the overall success of the product upon entering the m...

The Ellipta inhaler is considered to be a combination product in the same sense that a pre-filled syringe is. The Ellipta inhaler contains a drug that is combined with a device to facilitate the drug...

A straightforward way to classify a medical device is to go on the FDA website under their device classification panels page. This web-page allows one to locate their classification regulations by se...

A quality management plan is defined in our PMBOK guidebook as "a component of the project or program management plan that describes how an organization's quality policies will be implemented". This ...

A general online look at job openings for project managers (PM) lists a variety of skills ranging from interpersonal leadership skills to math-based analytical skills such as time and budgeting, or an...

I believe that in a perfect world, the ratio of success between interpersonal skills and technical knowledge should favor technical knowledge, especially in the science/medical field. One reason as t...

The company that I currently work at would be considered a project-based organization in that we conduct research on cell therapy-based products and processes. For example our projects focus mainly o...

I think it's quite clear that it is always more important to have an agreement transcribed into writing rather than have it established verbally, especially when occurring between two aspiring compani...

I work at a clinical research company that is involved with recent breakthroughs in immunotherapy. This includes treating conditions such as cancer, HIV, hepatitis, or pro-inflammatory diseases by pr...

As a master's student approaching my last semester, I can say that this course is unlike any other course I have taken in that it provides an alternative and even a more practical perspective on the m...

The role and responsibilities of a project manager easily varies depending on which organizational type they are placed in along with their preferred working environment. In terms of which organizati...

According to lecture, information silos are most prominent in functional organizations, meaning that the departments and project teams within the organization keep to themselves to the point that they...

The company that I currently work at would be considered a project-based organization considering that we conduct research on cell therapy-based products and techniques. For example the projects that...