Even though Non-Disclosure Agreement could have a perpetual time limit and should be theoretically protective to the commercial secrets between the two parties or within the company or institute. Howe...

I think most of these regulations mentioned regarding gift giving to physician are reasonable. The first topic I do feel a little bit rigid because it is not consistent with basic courtesy, which in n...

I think there are some significant differences between Verbal Agreement & Oral Agreement. Let's firstly suppose we take the form of verbal agreement, then we need to consider how the two parties s...

Even though I haven't involved in any types of organizations mentioned in this week's course, I have a preference to choose project-based organization as my ideal type of company to work for in the fu...

In terms of forming a project team, I think it's important to always find people who are qualified enough to participate their roles in the project, and meanwhile, have a good sense of collaboration a...

To start with the question: would it be more challenging to work as a project manager in either Matrix or Project-based organization? I think it will be so, based on more documents needed to practice ...

To identify and prioritize the risks for a project, you need to start with looking up in the design history files for other similar projects for reference. This will cost less time when you hold meeti...

These are very common causes for risk management mistakes. But in essence, these mistakes are due to lack of comprehensive knowledge of risk management. Here I wanna add one more mistake that could oc...

To run a risk management meeting, always follow the cycle of assess-evaluate-manage-measure. First thing you should do is to have quality member gather all members in the project team, because it is i...

Design review meetings are very necessary for ensuring that the present design meets the project objectives, because without doing so, nobody would attentively look for a possible deviations that coul...

If the deviation happens, firstly we need to locate which one or multiple parts could possibly contribute to the failure of verification. This is very important and may be highly related to small deci...

For Design Development Plan (DDP), I think the two most important parts are quality management plan and scope management plan. Because the quality management plan will tell you how to evaluate the dif...

Verification is one of the most important steps in the design control, that it not only can address the questions of whether this is effective enough to do what potential customers want it to be, but ...

The minutes in the meetings are very important because of they often specify how the team members are assigned their works and the deadlines, so that the responsibilities will be clear for the members...

Design Control is a broad definition of illustrating how you monitor the design process before it goes to the FDA for auditing. There are overall 9 files that should be accomplished: Planning, Input, ...