hi neb2 very good question i was thinking about this when i was looking at Dr. Simon lecture, what i believe is that a process approach is a managemen...
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, writ...
Hi luisa thank you so much for your input yes it seem like it wasnt the same but now i can do see the difference, because what i was thinking i gues...
Hi jnm22 thats very interesting anf very scary, because it could affect many of their customers and maybethe company might get sue to some tragic, so ...
I agree with both interpersonal skills and business skills because this will help to either fix or make a good deal with someone you are dealing. So y...
I believe that the most expensive is Introduction Stage, because the company is launching a new product. Further, the size of market for the product...
I haven’t had no experience in product failures but I can figure out ideas that how a product can fail. I believe that having a poor budgeting could m...
Hi everyone, When i graduate from my undergrad i was really lost on what career path i wanted to follow so i decided to do my master and maybe try to...
Unfortunately I haven’t experience with this type of documentation in the industry since i do not work yet for a medical device company that would all...
Hi Fady, I have to agree with chris vasquez, there is no need to revalidating something that is not being move. what is important here is understand...
I haven’t had no experience in this aspect but I did some research on different type of validation and I found that, self-documenting verification met...
Hey guys we have talk about IQ, OP and PQ about Syringe Filling Process – filling syringes with an injectable bone void filler and Vascular Graft Weav...
Hi Andrew, I have to agree with Fady Khalla on your IQ but never the less I think most of people have gave a lot of input on the syringe filling proce...
I wish i had experience on QMS for me it seems very important since quality management system can be defined as the implementation of dedicated activi...