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 in the nondisclosure agreement. These are:

1. The definition of “confidential information” that the NDA deals with;
2. Any exclusions from the…[Read more]

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 work in a team and how to cope/deal with other people of different department. It also teaches to maintain the patience in order to work with them.…[Read more]

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 personally I don’t understand the whole point of bringing your spouse to the meeting. Also, I do understand that gifts should be of certain amount only,…[Read more]

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 business venture with oral or verbal agreement.

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 going on and how to do it. I feel it is more uniform than big organization. In big pharma, it gets hard to do someone’s part since everyone do it…[Read more]

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 product line. Therefore, their main goal is product line too. This way it makes collaboration easier for companies since each department knows their role.

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 it. But when forming a team, relationship is also equally important. You need to have good relationship to work with each other. In case of…[Read more]

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 therefore, documentation review is very very important.

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 charged then corners will be cut and for standards of this magnitude, cutting corners can’t be a possibility.

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 safety margins.
B. Human factors such as social dynamics, conflicts of interest and values.
C. Decision maker: Amount of communication, and malicious attacks.

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 give highest severity to transference. DUring anytime in the business, if there are any an earthly accidents, or non–earthly accidents or someone sued…[Read more]

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 production. Biggest example of this is TATA Steel:

The metal giant was fined £1.98m after two workers suffered injuries to their hands in two separate…[Read more]

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 developing products within regulated industries (e.g. medical devices).

Because design controls must apply to a wide variety of devices, the…[Read more]

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 other bunch of them.