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 m...

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 b...

I agree with everyone. But looking at it from a different point of view.Cutting regulations will save more terminal patients however cutting down regu...

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 ac...

It would depend on the client's requirements. In many cases, the client may specifically require you to re-execute the entire verification and validat...

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 en...

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...

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 ...

The Thalidomide disaster was talked about in my undergraduate organic chemistry course. It emphasis the interpretation of new discoveries and most imp...

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 f...

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-M...

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 st...