When you go to work for a company that requires you to sign an NDA, or you are a company looking to hire employees under a nondisclosure agreement, you will generally see at least five basic elements ...

The best thing about this course is that it gives us (students) the practical feeling and more understanding about the industry and how it works. Rather than other courses, it gives us opportunity to ...

I think that is little absurd that physician's wife meal is not getting paid off. But then again why is physician's wife in the meeting? I mean usually these meetings are highly confidential so person...

The main difference is that written can be proven in court while oral might be little harder to do so unless you have a witness. Even then it might be tough. I don't think it is wise to start up a bus...

Just like you, I have worked in both the structure too. In my opinion, I definitely liked the small organization where everyone is doing everything. Because, in the absence of one, other knows what is...

I would consider a Product Organizational Structure for collaboration projects. In this structure, managers report to head of the company and analysts report to managers. Their main idea is the produc...

In my opinion, it should be both. Having departmental knowledge is very crucial in forming a team since that person needs to know in and out about every little thing about the department and how to do...

Documentation review is one of the main risk management analysis. Since the place I work uses all written documentations and no electronic, documentation review and should be under FDA regulated there...

Calibration, maintenance, safety inspections, regulations and standards all cost money but they are necessary to do it. Subscribing to these databases are simply an indispensability. If they are not c...

Factors contributing the risk index numbers can be divided into three different group: A. Overall context such as scientific unknowns, varying susceptibility to risk, positive feedback, and loss of sa...

I dont think I would give any option low severity because in risk management everything is equally important. You can not have less acceptance while moderate high mitigation. But I would definitely gi...

Risk management is not a lifecycle process! I totally agree to this that company should take care of risk management not only in the beginning of the production but during entire time of the productio...

Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and...

There are bunch of medical device that does not need clinical trial. Anything that has external use usually does not need medical device such as stretcher, medical gloves, assistive cane, walker, and ...

Issues with design controls: · assessing new product ideas · training and retraining of design managers and design staff · use of consultants · evaluation of the design process · product evaluation, i...