Generally, almost every company is going to be affected by external factors like the weather, politics, economy, competitors, and collaborators. There is really no escape as external factors are factors you cannot change, and these include opportunities and threats. These…   Read more»

People who are designated in branding control the product’s image. I feel like I may be able to do a good enough job in that department. I do not have much confidence in my skills to say that I will…   Read more»

In terms of marketing, we all have seen those drug commercials on TV where it is usually a patient describing their story and how this medication saved their lives, while the doctor on screen agrees and explains what it does….   Read more»

First and foremost, I think it would depend on the business you want to build, the location, the size, and the need for your product or services. For example, if you are going into the food business, you need to…   Read more»

In research labs, it seems like creativity and productivity is easier to achieve than in corporations. For example, research students, facility mentors, or researchers in general have a common goal they are trying to achieve. They are given the opportunity…   Read more»

I believe that many business owners or those that go into entrepreneurship prefer an LLC over an LLP due to the flexibility over ownership with the business. Typically, LLCs are easier to form than LLPs. In this week’s lesson, we…   Read more»

I do not have much experience with the industry and medical devices for quality control, but I do have experience with our quality control department at a laboratory with how they maintain accurate results, as well as team management and…   Read more»

Every user has provided good points on who would be beneficial to be a panelist in a FDA advisory panel. I agree with torikul as they have highlighted generally the most important people that should be included. I would like…   Read more»

In this week’s lesson, we have learned that quality assurance makes sure that all of the systems, structures, reviews, and evaluations meet the requirements to ensure the product or services are approved. Class III medical devices are more high risk…   Read more»

Even though minor errors are present, it is still a mistake either way since it is, for example, a class III medical device. No one wants there to be an error once everything has been set in stone and on…   Read more»

To me, there is someone that should be held accountable and responsible for the product mishap. I would choose not to buy that product. I agree with what vbp098 said. Most customers would notice the damaged label and potentially ask…   Read more»

I would like to say that I am in the beginning phase of my career. I do not think I would switch from the engineering role to the regulatory role. Honestly I have not considered a more regulatory role in…   Read more»

Good communication is the obvious and most important step before anything for two parties in question rather than becoming physical when disagreements arise. It is not necessarily to come to a set agreement, but just a way to discuss the…   Read more»

One of the common hurdles would be how much information there is available, as well as the accuracy of that said information. This mainly applies to principle eight being to consider all information for complete overall assessment. The lecture had…   Read more»

Going back to Week 1, we have gone over the difference between academia and industry in terms of job opportunities, benefits, pros and cons, as well as what path each one of us wants to take. From when I started…   Read more»

I believe that too much detail is when the project is overflowing with information that is unnecessary. For example, a project has a central goal or the solidified scope that was established during the planning phase with the team meetings…   Read more»

This is a great question since this tends to happen a lot in the industry or during any project. This is why during the initiating, planning, and executing phases of the project, it is best and important to hold regular…   Read more»

I believe that the connection within a team is extremely important to meet project goals and objectives at any job industry, not just biotechnology. Even though some people prefer to work alone on the project to meet the deadline tasks,…   Read more»

I do agree that having a BS is enough to employ you with a basic entry level position in engineering or in any other field in the industry. With four years of undergraduate study leading to a BS, this would…   Read more»

If I were to choose full-time remote versus being on-site, I would prefer working on-site. I only have experience at my current place of employment, but in an engineering position, I would still prefer to work on-site rather than remotely….   Read more»