I don't believe giving lavish gifts like the "old days" is permissible or appropriate in the modern pharmaceutical industry. As stated above, these gifts result in bias where physicians recommend prod...

While these rules or regulations may seem like they are too restrictive, they are necessary for the integrity of the pharmaceutical/medical device industry. While it is appropriate to pay for a physic...

In most scenarios, verbal contracts are legally binding. However, it is often hard to prove these contracts without written documentation. This can lead to parties not abiding by the contracts. Severa...

The most effective type of organizational structure depends on the type of project being worked on and the available assets. For instance, a Matrix or Functional organization may be better for a small...

For the project manager, it would definitely be easier to work in a project-based organization than a Matrix organization. In a project-based organization, the project manager only needs to work with ...

As stated in other responses, I think communication and setting expectations are of utmost importance. When a new manager is assigned to a team, it is important that this manager gets to know every me...

The pros of a risk assessment far outweigh the cons. On the surface level, the cons are that these plans may result in the project taking a longer time and greater expenses. However, in the long run, ...

Risk assessment is an essential part of the planning phase. All potential risks must be discussed so a thorough, well-thought out plan can be constructed. By doing so, the plan will run more smoothly ...

While it may seem that companies tend to outweigh reward more than risk (due to media headlines and such), I believe that most companies outweigh the risk more. First of all, liability is of utmost im...

I belive that both inputs and specifications have their intended purposes. In terms of actually constructing a device, it is impossible to do so based on solely inputs. Specifications are needed for t...

I do believe these columns are enough as they allow for the entire design process to be visualized without overly complicating it. I think the most useful aspect of a Design Matrix is that it tends to...

In general, clinical trials for both medical devices and drugs have the same end goal, to prove the safety and efficacy of these products for their given purposes. However, as many indicated above, th...

In terms of validation, I believe that the key is to always go back to the customer. By definition, validation is the process of ensuring that the device meets all of the customer's needs. If the devi...

Why seemingly similar and first-glance, validation and verification are quite different terms. Validation is the process of ensuring that a device meets the predetermined customer needs while verifica...

The most important part of meeting minutes is that they lay out deliverables for each team member and when those deliverables are supposed to be accomplished. Especially in a project with a lot of mov...