@Julienneviuya I understand that the spouse does have a good deal of leverage but I have heard that this ca lead to some very uncomfortable situations. As a medical device sales person it is hard to m...

I think I would definitely prefer the matrix organization in every position except for the project manager position. I believe that it is difficult to lead a project when the functional managers are c...

When it comes to building a project team it is definitely necessary to focus on skills and not personal relationship. I do not believe that it is healthy from work and personal life to overlap too muc...

I believe that personally I would be more fit for the upper management aspect of the procedures. I can better work with multiple groups and be able to reason out a fair schedule for groups to follow. ...

One aspect of low severity risk that people need to understand is that no matter what it is going to occur. You try your hardest to avoid these situations with sampling an strong quality establishment...

I was not aware that you have to pay to view the regulations. I am sure that it does help in the upkeep of the companies that are writing the regulations but I do think this favors innovations from cu...

Risk management meetings in my opinion are the most successful with a great deal of varying backgrounds. When creating a risk document it is important to encompass all of the possible negative outcome...

Validation in a way is an abbreviated version of the verification. It will allow the user to guarantee that the device or fixture is still functioning at its necessary caliber. It can begin with somet...

As you near the verification process the design review meetings become very important as they are a great opportunity for coworkers, management, or even document control to realize an issue in your ve...

For a verification that I was recently working on we tried very hard to make sure the verification was written in a way that deviation could be avoided. We attempted to run the test ourselves as well ...

I have been in many more meetings outside of the industry than I have meetings within the industry. In my fraternity we take very detailed minutes. Even though may seem this as unnecessary for a socia...

Through my experience I have seen very few cases when a validation is not required. I believe a lot of the requirements come from internal pressure and may not be directly required by the FDA or ISO a...

I was lucky enough to have the opportunity to work on a Test Method validation that went into a design review. One thing I have noticed is that people will often make it seem like they have something ...

For a study to be considered to have followed the scientific method it must have an experimental and a control group. It is sad to know people are being told they are being treated but they are actual...

I believe that if a clinical study is to occur the study should occur as a double blind study. Any bias that could alter the outcome of the study should be avoided at all cost. It is normal to want to...