I think you need to have both. Risk management should be taken into consideration the entire process, but the final approval should be done by different people in risk management. This makes me think ...

I don't know what company you're talking about and I'm not sure if I'm looking in the right place (all I can find is avengers stuff). That's good that they're checking each step. There's a lot of aspe...

Well judging from what I've seen a few things could happen. The first is that you notify them and try and fix the problem. If they're slow to respond then you would start looking into other vendors. I...

I agree with what you you guys have said, I just want to add that people with experience on projects are a great asset when determining issues. They may have seen certain things that came up and negat...

I currently work in a pharmaceutical company, and we are in the process of getting all of our equipment and process verified and validated. We need to ensure sterility, appropriate amounts of product,...

I'm not sure there is one. Every stage has it's role to play. Maybe you could say that starting off strong is important, but the others can't fail or else the entire project is a failure. Did you have...

Manolo you didn't really address my point of even if there were no regulations, the cGMP violations would eventually cause some problem. Probably people getting sicker/dying. That would cause lawsuits...

Anthony, I'm not sure that employee and contract payments are the issue in that. Full time employees get salary, so they usually would be working on another project/aspect if they finish early. Contra...

From what I've seen there's a few things that happen. When making a timeline, if the task seems similar to previous tasks, they will use the previous task's timeline as an indicator of how long it wil...

I'm not why you have a question about this, it seems pretty straightforward to me, even if you look at this through a purely financial lens as opposed to a morality lens. I assume that you believe tha...

Building in delays is a good idea, but one thing no one has talked about is how long that buffer should be. You can't make it too long or else you may give the impression that the project shouldn't be...

I'm not 100 percent sure on what your point is but I'll try to answer to the best of my ability. The only situation I can see when that might be an issue is when a project leader gets promoted to a h...

If you look at every person that works their way up in the company, there's one thing they always have: strong interpersonal skills (or are at least improving those skills constantly). There's a sayin...

ajm73 I agree with your sentiment that some countries will not recognize it. They will definitely have some of their own specified regulations. For example, most regulatory agencies as I said before h...

This is an interesting question and I haven't heard of such a thing before. The short answer is: they have to worry about it. The FDA is a national regulatory agency, but states have the right to pass...