Dr. Simon, I appreciate the material that you are teaching in this class as it is extremely applicable to the industry. This course has allowed be to...
False Claims Act violations can result in the following: • Damages penalty triples the amount of money defrauded from the government • Claim penalties...
Currently, I work in a Matrix Organization which is project-based, where there is a representative per functional group that is responsible for succes...
I am surprised to hear as well that instructions for use (IFU) and labels are deemed as the least effective way to solve residual risk since the amoun...
As hc225 mentioned, from experience in the industry, AQL levels are in place for the critical dimensions from the technical drawings of the product. Q...
Hello, I have recently participated in a Medical Device Single Audit Program (MDSAP) audit and am currently preparing for the second part of the same ...
Hello, General consequences of insufficient design controls: • Design not meeting the needs or wants of the intended market/customer • Faulty product ...
Hello, I have some experience developing Gantt charts through my undergraduate program and through industrial experience. From my perspective, some i...
As a Project Coordinator who takes the meeting minutes from each meeting, I agree with Dr. Simon’s push on the importance of taking meeting minutes. M...
Through my experience working as a Project Coordinator in the medical industry, I have encountered a two verification tests that didn’t meet the desig...
Guidance for Clinical Trial Sponsors: I would select to be a sponsor for clinical research because they are responsible for initiating the clinical i...
Marketing research indicates that approximately 80% of visual information is based on color and a person can only keep 3-4 pieces of information store...
From experience in the industry, the company’s Marketing lead for that project will reach out to their sales team in each region or country and have i...
Marketing is having the ability to understand the customer’s needs and wants and utilizing those specific tenders into design inputs and marketing out...
Private companies, in my opinion, have more of a small business feel even though they can be very large in size. They have a small number of owners, t...