since already many have talk about some of the examples, there are some benefits of ECO. following good ECO practices it will make thing easier when documenting a full history of what change have been made to a product and…   Read more»

since everyone have mention about why SOP should be required during research phase, i want to add some information about SOP. SOPs should be reviewed by appropriate individuals. Reviewers could include colleagues who will be using the SOP, Quality Assurance…   Read more»

yes i do believe that Guidance documents are very important because this documents are prepared for FDA staff, regulated industry, and the public that describe the agency’s interpretation of or policy on a regulatory issue. Guidance documents include, but are…   Read more»

i dont have experience with this, and since a lot of student have answer i want to add some information about the Authorisation procedure. it said that the Full copies of the marketing authorisation application file are sent to a…   Read more»

The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of these regulatory challenges by the Food and Drug Administration. According to a survey funded by the Institute for…   Read more»

It seem that a lot of people here had agree with me that Clinical research wouldn’t take this career path, one thing that I do like was that CRA can travel for free and work for home that’s one of…   Read more»

Very good question, this simulation have help me understand how actually, some of the stuff I would be dealing in the industry and how I have be knowledge about many factors. All the simulation were very interesting, each dealing differently…   Read more»

Yes, I do have to agree with Fady Khalla post, it can varies depending on the application that this device is going to be used. As fady khalla mention, depending of the used of the device the risk could change….   Read more»

Hi neb2 from the research i did from this week lecture i found few examples that might help you, there is a lot of them but im just going to provide some of them. for NSR; -Digital Mammography [Note: an…   Read more»

Pros to internal audits When an internal audit is performed you can be sure that a proper accounting system is going to be introduced into your company. If you have never worked in an accounting office or seen what goes…   Read more»

It is true that for startup companies not having preexisting GMP as a foundation it will cause a lot of problem, like everyone has mention in this post. What we need to look at here is that even though it…   Read more»

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 and manage the…   Read more»

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 could affect the quality of the finished product. There must…   Read more»

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….   Read more»

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 found out…   Read more»

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 level, they…   Read more»

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 of research and development, testing, and…   Read more»

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 different ideas, or plan…   Read more»

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…   Read more»

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 the only experience I…   Read more»