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 management strategy, where a managers is able to control an...

GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that...

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 guess it was different thank you for the clarification...

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 do you know how they were able to fix or how they ...

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 yes you kind need both of this skills at the same ...

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 is initially low and thus sales are low. Costs o...

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 make a product fail, sometime teams look at differe...

In Dr. Simon Lecture we learn 4 things that a product manager need to have which are: -Understand factors that affect the product sales -Compare competitive products and services -Stay informed about ...

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 learn more and maybe figure out by than which care...

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 allow me to see or do this type of documentation, so ...

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 what went wrong with me machine it seem that some ...

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 method is the traceability matrix. This method is par...

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 Weaving Line – weaving the polyethylene fabric tubes t...

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 process for IQ, OQ, and PQ. so im just going to say tha...

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 activities in a project to obtain continuous improvement...