Initiating a project idea is the hardest part of project development because if done incorrectly, your project will fail and you will waste time and money. So how would one avoid this? This is where b...

My opinion applies to the business case especially coming from a family who owns and runs a business. A good project manager can run a business case based on his analytical skills and critical thinkin...

I agree with everyone. But looking at it from a different point of view.Cutting regulations will save more terminal patients however cutting down regulations can also be harmful for the long term. If ...

Yes it is a living document and i agree with everyone here. However, you can't look at this like a file on your laptop. These changes and processes actually cost money and time. When you are hired for...

It would depend on the client's requirements. In many cases, the client may specifically require you to re-execute the entire verification and validation protocals. This can be costly but if the clien...

Agreeing with everyone, yes both of the files are useful and in some instances as mentioned above, one file is more useful than other. But at the end of the day, both files are there for a reason. My...

My understanding of it is, that it depends on case to case bases. It depends what your drug, device, or both intend on doing. Keep in mind, some risks may not appear in short term clinical trials. Or ...

I would like to share my interview experience on this post. I was interviewed for a position and the manager specifically asked me about GMP and what it meant. So in the real life examples, a company ...

The Thalidomide disaster was talked about in my undergraduate organic chemistry course. It emphasis the interpretation of new discoveries and most importantly allows us to see that not every new disco...

I personally do not have any experience working in any industry. But from my understanding, I would imagine the company I work for would have either fall under FDA or EU. So under EU, the notified bod...

As far as my understanding, Guidance documents are not mandatory but it a template for reading directives. Guidance documents in EU, I would rank NB-MED higher than any other because it is written by ...

It is easier to get devices approved in the EU because it requires less data and evidence compared to FDA. For example, FDA would require an actual study based on a big sample where in EU, you may be ...