I believe that the only responsibility that the sponsor cannot outsource to any CRO is the overall responsibility of the clinical study. I think that ...

Hi All, I believe that all of you have touched upon very valuable points. I would like to emphasize that pre-clinical trials (animal trials) are not...

As everyone have mentioned, These simulations are a very useful tool to mimic what usually occurs in the industry. Although I sometimes think that the...

Hi Neb2, From my experience, you might have two functionally similar devices but they may have different risks. For example, an infusion pump that is...

Non-conforming materials is a very common issue that almost all manufacturers deal with on daily bases. it ranges from regular suppliers to product co...

Hi All, Yes, I agree that the ambiguity of GMPs makes it difficult for startup organizations to find the right way to implement them. When I worked i...

Hi All, This is a very interesting discussion so far. I want to look at this situation from a different prospective. If I am a manufacturer that is l...

Hi All, This situation is usually handled on a case by case basis. In some cases, when the regulation is changed or updated, guidance documents are i...

This is a great question, and I am currently experiencing that in my current position. Most of the time, projects that are given the GO decision are e...

I agree with all the aforementioned comments that all these roles are crucial for a product manager. The one point that I have to elaborate on is the ...

I have had the privilage to lead the root cause investigations on two recalls in the market. The first recall was regarding a mislabeled lot of produc...