Posted by: @dbonanno1 Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you…   Read more»

Posted by: @ljw3 I’d like to add that criteria for giving and receiving gifts often applies to both sides in a lot of company policies. Specifically, my company’s policy is that I am not allowed to receive gifts of any…   Read more»

Posted by: @traceymraw I have not worked in a company that has hired consultants, however I think consultants would be most on short term projects. If a project requires extra people working on it or someone with a specialized skill…   Read more»

Posted by: @quanzi A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk evaluation, risk controls, the evaluation of overall…   Read more»

This thread is loaded with some of the most common mistakes in risk management. Here are the top five that I have been able to find: *A lack of security & business alignment *Limited visibility *Putting frameworks first *Giving equal…   Read more»

Posted by: @pjf22 When performing the Risk Assessment of a new medical device, I think all three tools serve a purpose and can potentially identify risks that the other do not. I also believe that each tool can be used…   Read more»

Minutes are very important. Especially on a day when you’re just out of sorts.  Even before zoom people would zone out on meetings, make lists to get them through the rest of the day, plan dinner, etc. It usually isn’t…   Read more»

Posted by: @zbw2 China is one country with a comprehensive design control system regulated by the Chinese Food an Drug Administration(CFDA). since 2013 the CFDA has been revamping their medical device controls. in march of 2015 the CFDA “revised [their]…   Read more»

Design controls are how the FDA check that the medical device has been developed safely.  It also ensures that the product you have placed on the market (or are attempting to rather) has been well thought out. There are nine…   Read more»

This thread assuredly posses an ethical dilemma. My goodness, what to choose. At the end of the day, it is likely that the next Henrietta Lacks has, in fact, chosen to keep their tissues out of the hands of scientists….   Read more»

Hi @llefevre! You’ve giving a wonderful overview of why placebo is used as well as the fact that it is not harmful in anyway to the patient.  Coming from the perspective of the COVID trials, I do think that once…   Read more»

Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

Posted by: @hm243 Most known companies as stated above, follow C-Corp setup, while very few follow an S-Corp. The major difference between the two types of corporations is the taxation. With C-Corp, there is a required double taxation. As a…   Read more»

Posted by: @sahitya-sadineni After watching the videos from this week’s lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position based on the type of company it is? For me…   Read more»

Posted by: @srg36 I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2…   Read more»

Posted by: @devarshi-joshi According to me the most important 5 success factors are:1)Agreeing on the project goals2)Effective Communication3)Develop clearly defined plans with assigned responsibilities.4)Managing project scope effectively.5)Making sure of management support. So how are these factors individually important for a…   Read more»

Just now in another thread a young lady asked “How do you track when a project began to fail?” Now I may not have gotten the wording completely right but you get the picture.  My response to her was to…   Read more»

@eowinomsm-edu Greetings Liz, I completely agree with your definition of what a project failure is considered to be.  I think further if the project does get done but grossly behind schedule it failed. AND if the project has to be…   Read more»

Posted by: @mduru I think it would be appropriate to say this topic is like a double edge sword. Just as with any controversy or disagreement, I think dialogue is the best way to go about it. Both side need…   Read more»

Posted by: @hm243 In industry, research is done to make discoveries for products that can help people right away, while in academia, research create results for the long run. I feel that both types of research are important and necessary….   Read more»