I have experience as a Quality Engineer. One of my tasks was to manage the equipment maintenance schedule and order calibration services. During produ...

I think in order create an innovative design that passes all regulatory compliance, it should have an effective Validation Plan. The validation method...

Although I worked for a company before with a Team, I don't have experience Initiating and Managing a Project. I think that as an Engineer becomes mor...

In order to reduce the time and money needed for a project while also increasing the chance for a successful product is to gather up all previous meet...

Hi everyone. My name is Brandon Klavansky, and I'm a BME MS student at NJIT. I'm looking forward to connecting. Here's my LinkedIn:

I think that email communication is used for official information that includes meeting invites, task delegations, and announcements from the manager....

I think it depends on what you mean by Slack Time. Unexpected delays can happen and extra time should be given for cases such as failure in Validation...

I agree that feasibility studies will improve the chances of success in the Design Control process and help a project lifetime. Innovative projects ar...

Using ES, EF, LS, and LF is very helpful for planning for any contingencies. Many factors can cause delay in a schedule such as not thoroughly examini...

I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA s...

Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can't change the testing parameters. The bottles' labels mus...

When Verification tests fail, I think that the best approach is to first evaluate whether the model still fills the need of the customer. The testing ...

In my personal experience, I had to jump into a role working with a team in a functional organization, not yet knowing how organizations worked and th...

The Design verification and Validation test the design of your product. In an experiment, there are always statistical analysis to determine the signi...

Determining the spec with tolerances is the most important part in the effectiveness of the design. It really depends on the application and market in...