since already many have talk about some of the examples, there are some benefits of ECO. following good ECO practices it will make thing easier when d...

since everyone have mention about why SOP should be required during research phase, i want to add some information about SOP. SOPs should be reviewed ...

yes i do believe that Guidance documents are very important because this documents are prepared for FDA staff, regulated industry, and the public that...

i dont have experience with this, and since a lot of student have answer i want to add some information about the Authorisation procedure. it said tha...

The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of thes...

It seem that a lot of people here had agree with me that Clinical research wouldn’t take this career path, one thing that I do like was that CRA can t...

Very good question, this simulation have help me understand how actually, some of the stuff I would be dealing in the industry and how I have be knowl...

Yes, I do have to agree with Fady Khalla post, it can varies depending on the application that this device is going to be used. As fady khalla mention...

Hi neb2 from the research i did from this week lecture i found few examples that might help you, there is a lot of them but im just going to provide ...

Pros to internal audits When an internal audit is performed you can be sure that a proper accounting system is going to be introduced into your compa...

It is true that for startup companies not having preexisting GMP as a foundation it will cause a lot of problem, like everyone has mention in this pos...