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 ind...
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/int...
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...
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 sai...
Hm, this is interesting because I thought all validations were essentially a holistic approach. You don't really validate just one aspect of the produ...
Our validation is done on SOPs, equipment and the assay for the drug. For the assay it is tested a certain amount of times against a standard to make ...
I think writing SOPs are a very hard thing to do. No only do you not know when it is too detailed or not detailed enough, as the author its hard to pu...
I think it depends on your department. I work in development so we only deal with DHF and if you were in manufacturing or production it would be a DHR...
I haven't used an ECO but I think it is used more in manufacturing/ production and not in development as changes made there are much easier. My only q...
Hey I think in pharma as mj34 said it is usually from the patient and Doctors. They provide us with feedback on how the drug is working and any advers...
Luisa gave a very good answer to the question. I will add the while both process focus our the same outcome they are also very different. The design V...
I think the DHF is more useful than the tech file. With a complete DHF it shouldn't be difficult to get the actual design of the device as that is whe...
Hello, I also believe that a DHF is not a living document from my experience and just from the purpose of it. It is for the initial design and any cha...
Hey so what did you end up filing it as? This is interesting as I didn't know you chose the notified body unless you work in regulatory then that make...
So shouldn't the EU also have systems in place to prevent tragedies? Shouldn't they learn from the FDA and take precaution? I personally think that th...