Project management processes and design controls are similar in a sense that both are carried out along the duration of planning the project. Project management processes are the “how-tos” of the project whereas the design controls explain the design method….   Read more»

I think you bring up a great point. In Medical Device/Healthcare Project management patient safety and data privacy are at stake. Healthcare is indeed heavily regulated due to laws concerning patient confidentiality and HIPAA compliance. With these regulations, obtaining approvals…   Read more»

As a person without experience, from my understanding the early start date is heavily determined by the dates set in the critical path whereas the late finish date depends on all paths. When multiple paths are presented, the early start date…   Read more»

As Dr. Simon mentioned, most of the time, the risk management team is often the same people from the project management team with the project manager to lead. In my opinion, the only con to having the project management team…   Read more»

To find out the procedures, guidelines, and information that already exists within an organization, you would go for the Organizational Process Assets. The role of the Organizational Process Assets is to implement policies and procedures that already exist with the…   Read more»

These are some great questions! Although the the side effects and financial risks outweighed the profit, I believe the implementation of the vaccine mandate did indeed change the course from the initial financial risk assessment. Because of this, from an…   Read more»

There are many different circumstances that can cause a team member to perform. As a project manager, I think it is essential to ensure that the regardless of those circumstances, the project comes to completion by the deadline. In order…   Read more»

From my understanding, the project life cycle does not necessarily occur during the product life cycle when the output of the project is the service. In this case, the project life cycle would go through initiation, planning, execution, and closing…   Read more»

Most commonly, working in a group consists of individuals or smaller teams splitting up the work evenly and bringing the pieces together for a final product. While I do agree with the other responses, I think the division of work…   Read more»

I personally prefer to work with a boss that is more hands-off. Micro managing can cause the members of the team to refrain from personal expression. With a laid back approach to managing, you encourage members of the team to…   Read more»

One of the main similarities between functional and project-based organizations is that both organizational structures involve collaboration amongst multiple departments. Both structures include one member or, in the case of project-based structure, multiple members from different departments within the organization….   Read more»

In medical device management, I believe the matrix organizational structure is most common. The matrix organizational structure allows all departments to collaborate with each other and provides good management of resources. For organizations with large projects, this organizational structure incorporates…   Read more»

I think this is a great point. The FDA presents a mission statement that backs the responsibility of protecting public health by ensuring safety, which I assume the vaccine mandate is an example of. As you mentioned, the FDA presents…   Read more»

Although @devdesai raises some good points, from an ethical perspective, I have to disagree. Yes, the presence of antifreeze constitutes as ways of preservation but how ethical is it? There are quite a few ingredients that the FDA approves of…   Read more»

Great question! As discussed, the role of the regulatory department includes product development and post-market management which require some background of project management. Project management is crucial for those with regulatory roles. There are many different subcategories within the umbrellas…   Read more»

Megaprojects interest me the most. As a research scientist for a major cancer hospital in NYC, I’ve been a witness and participant in many different smaller projects where few people and/or activities are involved throughout the process. Typically, they consist…   Read more»

Hi @mmd55 , I completely agree with you. Like yourself, I’m also drawn in to difficult and complex projects. Smaller and more simplistic projects just don’t seem as rewarding as one with many different components! It’s like taking a class…   Read more»

As a project manager, it is essential to identify a problem and to come up with a resolution. Many teams will consist of those with different viewpoints of how an objective may be achieved and in time of conflict, it…   Read more»

In my experience working in medical laboratories, I often take part in executing one of many pieces of a project. Before taking this course, I was only familiar with the role I played within the laboratory. This course is beginning…   Read more»