I agree with the above statements, but in addition, missing a milestone is a bad thing no matter how you spin it. Take it as a learning experience for future improvement you may think, but in reality ...

I think the best way to avoid an inaccurate estimation is to actually have members on the team that have done similar tasks before, you wouldn't want to take the opinion of an inexperienced person. Th...

jr377 taking into account how long the built in buffer should be is an important point to bring up. As with all parts of the project this too will be a factor that impacts the budget. The extra time a...

In my opinion a good way to avoid scope creep is to have a highly efficient planing stage prior to the submission of a final scope statement. Make the most out of each meeting and get all ideas on the...

Honestly I don't think there is a grey area on when to shut down or continue a project with an assessed risk. I think that when a risk analysis is done and the results are shown to the company/stakeho...

I think that the best way to prevent employees from going off on their own and making decisions that will effect the whole project, is to have a clear scope baseline. As a project manager you should h...

"High Complexity Tests This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as high complexity under CLIA. Laboratories under CLIA an...

The lab I work for purchased a new automated diagnostic machine about a year ago and I had the luxury of validating the device for use. It is called nanoString DX digital analyzer and prep station, th...

test

In an ideal world a company would fully fund projects large and small, but I think priority will ultimately come down to a risk reward analysis, how much money a company is willing to put into a proje...

In addition to giving ample time for members of the project team to review documents before their approval, I think that it would be beneficial to have frequent short meetings in between official desi...

I haven't had the opportunity to work in industry yet, but if I could choose one of the nine parts of design controls to focus on I would choose design validation. Having a product that is ready for a...

I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in lecture, the approach to regulation regarding drugs...

Over a medical device's lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk associated with the device. If this happens there is a ...

With the standard pill, not containing the event marker, there were 6 clinical trials done to get the drug approved. With the addition of the marker the new combination product required new clinical t...