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 sta...

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 sen...

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...

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, ...

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 ...

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 sure it falls within in range. The machines have t...

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 put yourself in the shoes of someone who knows nothi...

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. Also an easy way to differentiate DHF is all enc...

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 question is if it is a major change what are the fo...

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 adverse effects. Also on the company end even when a dru...

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&V focuses on the design while the process V&a...

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 where the SOP is. The tech file is just a snapshot an...

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 changes that will be made shouldn't alter the initial...

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 makes sense. Even still I believe there are checklist ...

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 the FDA might prohibit research and great products t...