I have not even had to identify risk perspective from that large a range before, but I have seen different perspective about risk in my team. I worked...

I worked on a project where we had to collaborate with a different company or our validation projects. Because I was more familiar with the system and...

I currently work in the pharmaceutical industry, most of the projects I work on was around building up our current labs to GMP standards. However, I h...

I also agree that the culture of the group is very important. It can get off to a rough start if the initial team is not very compatible . This is esp...

In the event that you are modifying a device to the point where you may need to have software modification, it will need validation. If it is a modifi...

In worked on a med-device for soft bone injuries that that I built with a group of 4 people. The design was based on a modification to a cam walker bo...

Intellectual property is one of the most important things to consider protecting when making an agreement. The contract should consider the benefit an...

I think the matrix organization is best simply because the advantages are centered around multiple control. There always a second opinion. Thought tha...

I would not form a team based just on personal relationship. I would form a team based of the individual that best understand the objective of the pro...

When working on projects where other companies are involved. I think that the most efficient type of organization is the functional or matrix organiza...

There are many ways risk are identified and dealt with in a company. In every department there are different risk factors that are considered for diff...

I think that avoidance is of the lowest severity simply because the problem is not his, however depending on the drawback to that product function it ...

I think that is anything in industry can easily lose its real purpose in the face of company agenda. Risk management should exist to insure that the u...

I believe that meeting minutes are extremely important, even so that there is a person at my job that would take notes during the meeting and then typ...

In agree that the FDA may be more interested in insuring that the design controls for a specific device is within the FDA standards. For example, when...