That is a little scary to me as cost shouldn’t really be an issue in a clinical trial over quality. Not saying that the quality will be bad in other countries but it is a risk that is being taken…   Read more»

Both versions of this course is very useful. I took both of them while working and wish I took it before I started working as they do give you an idea of what to expect in industry. Maybe it should…   Read more»

Hey tn58, that is true. A problem in the trail even if it gets fixed is a big loss. Not only is money spent during the investigation but no matter what happens after it, it is bad press. With us…   Read more»

Lol that is funny. When I was in school I thought being a CRA was cool and a easy way to travel for free and work from home! I have a friend who is a CRA and now that she…   Read more»

I’ve been ok an investor double blind study ( data was collected in real time and we didn’t know who had placebo and who didn’t). On the scientist side of things it’s exciting to have samples run it and see…   Read more»

My company had a study go on “pause” due to an unexpected side effect. The people enrolled were not administered anymore doses and others were prevented from joining until the problem was solved. An investigation was done and It had…   Read more»

I don’t think it’s possible because yea cost is a factor but it has to make sense. If the study is focused on a disease that predominantly affects that area yes but if it doesn’t I doubt it. My company…   Read more»

I think technology can make it both easier and harder to comply with GMP regulation and they key is to update along side of regulation. It is important to review the guidelines and have everything understood before improving processing that…   Read more»

I agree with Luisa, this situation makes room for contractors to be hired as it is easier to hire and terminate and less costly than a company employee. This is why timelines on the PM side are so important as…   Read more»

Yes usually an outside contractor can come in and perform the audit. Also can’t employees be trained? I know it is not the same thing but in my company we have a safety audit team that is composed of just…   Read more»

Hi I also agree that it would be more of a60-40 situation where maybe 40% of companies would chose no GMP. Yet those who do will have a competitive advantage in the market and have more trust from the consumer….   Read more»

I agree with Fady that this should be a case by case scenario. Depending on how far along the products are. If it is not handled like that a lot of money and time will be spent and it won’t…   Read more»

I also don’t think the ambiguity sets companies up for failure. There are so many different types of assays and ways to create products within medical device and drugs that it’s almost impossible to be specific. So it has to…   Read more»

Hey all, thanks for sharing your experience or even things that were in the news.Pfizer also had a recall on three of their drugs in 2014 once it was reported that a container of one drug had some capsules that…   Read more»

From my experience and knowledge a lot of things get killed but really get placed on the back burner as priority shifts with the intent of getting back to it later. As Michelle said it really depends on how far…   Read more»

This was new to me as I had no idea something such as a product manager existed. I think the most important would be for the to stay on top of the industry and market data as everything else seems…   Read more»

Completely agree it is a combination of both. While your business training is needed so you know to keep the company first it is all communication/interpersonal skills. That is why they don’t just send anyone to make deals but usually…   Read more»

I think the most expensive part will always be the research and development phase as a lot of money is wasted by ideas that don’t work or even scaling the idea up and down. Money is spent from testing, contracting,…   Read more»

Hey, In my company everytime an equipment that has been validated gets moved to a new room it has to be revalidated IOQ/PQ. Similar to what sns34 said it is due to the conditions of the new location, and anything…   Read more»

Hm, this is interesting because I thought all validations were essentially a holistic approach. You don’t really validate just one aspect of the product but everything that will touch/create it so in a sense it is always holistic no?