There are multiple aspects that are considered in making a confidential agreement that make the agreement binding, enforceable, and agreeable by both parties. In the agreement, the definition of confidential information is clearly listed and defined for the individual, which…   Read more»

Non-compete agreements are pretty common in any industry. In the jobs I’ve worked, each one had a non-compete agreement that I was required to sign before working. This agreement basically protects the company from an individual taking all their knowledge…   Read more»

This gift-giving in the “older days” was abused by some big companies, which was over the line and unethical, namely in the case of perdue pharma. Perdue Pharma, a company in the healthcare field, was marketing opoids, which were painkillers…   Read more»

The one organization setting that would be right for me would be a project-based organization because of the familiarity and single focus on the project. While working on this type of team, I am working with the same team members…   Read more»

This is a common scenario in corporate organizations because of the age difference that comes with their experience levels as well as their different styles of working. In this scenario, what usually helps is to hold a meeting between the…   Read more»

Maslow’s hierarchy of needs tends to focus on the self-development of the person and can be likened to the organization one works at as a whole. Beginning with the psychological needs of a person in the organization, they would have…   Read more»

A minority of biotechnology companies would look at the rewards compared to the risks because the potential to reap the benefits of the reward is better than the associated risk. The majority of companies bear more risks than rewards because…   Read more»

I think the most important risk management stage of the project would be during the manufacturing stage because of the different risks that were not accounted for in the product design of the project. In the planning stage of the…   Read more»

In order for this device to get approval from the FDA, the risk management process would roughly look like the following: The device would undergo the usual process for FDA approval of a level 3 medical device. In terms of…   Read more»

In the design review, multiple departments are included to cover all their bases in different aspects, including design, quality, and manufacturing, among others. Having multiple people with experience in these reviews gives the product the optimal rate of success, so…   Read more»

There are a couple different forms of validation that I have encountered in my work experience that are interesting in their own right. One of the types of validation is process validation, where in the environment of manufacturing, a process…   Read more»

On the medical device side of a company, strict standards are in place for good reason due to the inherent risk of potential harm and influence on human subjects. In the type of industry I was in, change was very…   Read more»

Designing verification tests is not something I have done from scratch, but I have some experience working in a lab and using these skills for tests. In a laboratory, many of the test methods are not made from scratch due…   Read more»

Validation is very important no matter which field it is encountered in due to making sure that this piece of equipment, whether it be medical devices or something as simple as a blender, The process starts with installation qualification, which…   Read more»

Corporate responsibility is pretty important to companies due to the long-lasting effects that a company can have on people through their products. This type of responsibility tends to be very wide in terms of what a company does and their…   Read more»

One of the most important good clinical practices in the FDA documents I found was 21 CFR Part 50, which has to do with the protection of human subjects, namely informed consent. This is such an important concept to grasp…   Read more»

Intellectual property is a tricky subject because the term of ownership becomes less clear in the way multiple parties are involved, but in the case of clinical trials, it is very clear who owns inventions. Before a clinical trial takes…   Read more»

Clinical trials are expensive as well as time-consuming, so reducing a device to a semester is a very tough task to do and is impossible. In the capstone class, students are working together to get primarily a grade in the…   Read more»

The qualifications of salespeople I’ve encountered are very different, which is mainly based on the chemical industry, where most of the people I knew to be salespeople had a technical degree and their main degree wasn’t in business. There were…   Read more»

In the transition from engineering to sales, in my experience, I’ve seen people complete engineering degrees and then use that engineering degree in a sales position in a company. Most people have gained experience through positions such as retail at…   Read more»