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 to be…   Read more»

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…   Read more»

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 encompassing…   Read more»

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 following…   Read more»

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 drug…   Read more»

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&V focuses more on…   Read more»

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…   Read more»

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 design….   Read more»

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 involved and…   Read more»

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 to coming to market quickly but at…   Read more»

Hey I agree that this is true but it also makes me worry about products coming from the EU. Due to the fact that the process is quicker and easier are product equally safe? I can’t imagine shortened/non-existent clinical trials…   Read more»

Hey gh56, There is a graduate course on BioMEMs with Perez and it is very interesting where we read plenty of articles about the current practices. Yes I have been fascinated by 3D printing for a long time and I…   Read more»

Hi Andrew, Yes this is a very common trend, that depends on company size but. My company is fortunate enough to have comparative medicine onsite so they do a lot of our pre-clinical animal studies but we do use CR…   Read more»

Hey, I also work in the pharmaceutical industry but I try to keep my self up to date with 3D printing for regenerative medicine along with BioMEMS. These two trends are huge and I personally think really are the future….   Read more»

My company also has rules against gift giving for protection against lawsuits. Personally I think instead of restricting the process they should just ban it. Doctors shouldn’t have to be bought and should just go off of the science or…   Read more»

I find that to be very surprising as I did not know verbal agreements were something that is acknowledged by the law. The quote above says “as long as there is enough evidence” but what is enough evidence? An email…   Read more»

I thought this course was very useful as well and I am already working in industry. I liked that you showed us every division within medical devices and their importance. Honestly I wish I took it before I started working…   Read more»

As a lot of people have mentioned choosing your team members is not that realistic in the real world. People are just assigned projects based on their role. It would be best and helpful if the person is also knowledgeable…   Read more»

Hey, Thanks for the link. If I were to start my own company I would go for a matrix organiation as it makes the most sense to me. I think the combination of functional organziation and project base divison is…   Read more»

I am not sure what type of organization my job is. It seems to be a mixture of functional and matrix. Project managers are assigned to a project from their manager and the project can expand to different departments/groups depending…   Read more»