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 documenting a full history of what change have been...

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 by appropriate individuals. Reviewers could inclu...

yes i do believe that Guidance documents are very important because this documents are prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy...

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 that the Full copies of the marketing authorisation a...

The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of these regulatory challenges by the Food and Drug Admin...

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 travel for free and work for home that’s one of the...

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 knowledge about many factors. All the simulation were v...

Hello everyone, As we come to a close to finish AMDD we have learn a lot of new material that we can apply to our careers. I know some of the people here have jobs and had seem some of the material we...

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, depending of the used of the device the risk cou...

Hello everyone, so this week lecture is about Clinical Research and we learn a lot about it, i personally do not see myself working on this the reason is because it doesn't seem fun or i don't think i...

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 some of them. for NSR; -Digital Mammography [Not...

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 company. If you have never worked in an accounting offic...

In Dr Simon, he talk briefly about correction vs corrective action. What I understood from the lecture Is that correction is any action that is taken to eliminate a non-conformity, and corrective acti...

In Dr Simon he talk about Corrective and preventative actions (CAPA) and this topic is important to know and we know that CAPA system aims to identify, eradicate, and reduce the chance of adverse even...

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 post. What we need to look at here is that even thoug...