Despite not working in quality control, I know it’s essential to stay on top of new regulatory requirements for production standards, maintain safety testing programs, and trace any product recalls to their source. Continuously monitor and improve manufacturing processes, and…   Read more»

I think working in a workplace with diversity is encourage is an advantage I think all companies should have. I learn and respect all people that has a different background than me. They teach me things that I haven’t experience,…   Read more»

Good question. I would think ethics and quality control go hand to hand just based off this week’s lectures. The FDA ensures the quality and safety of the medical device as it is being practice. Good ethics is heavily enforced…   Read more»

Since I have a bachelor’s degree in business administration with a concentration in marketing and communication, I think I would pursue a role in the marketing department of Quality Assurance. I enjoy branding and understanding my target audience/ demographics. Developing…   Read more»

@justinwilliams I think the pandemic taught us that the world was not prepared for such an outbreak.  As for the US, we avoided looking at the data because at the onset of the pandemic, we had an administration that didn’t…   Read more»

I think that working with people with different backgrounds brings diversity in the workplace.  It can be refreshing to encounter people who aren’t from where you’re from or who think like you do.  It gives the opportunity to have an…   Read more»

As a QC Scientist for many years, I believe that having a general sense of organization is necessary.  Knowing how to set up your experiment can help save time as your not having to stop in the middle of your…   Read more»

@cmassah15 I agree with your point of view on this topic.  Consumers put their trust in businesses that are creating products for the marketplace.  That trust is broken when shortcuts are taken and the consumer isn’t aware until the deception…   Read more»

While I have not considered a move to regulatory, I have seen a fair amount of my colleagues do so with much success.  Being that I have a Chemistry background working in biotech/pharma, generally, a BS degree in any science…   Read more»

As a Quality Assurance Specialist, my job is pretty routine depending on the day.  I work for a biotech/pharma company that manufactures immunotherapy treatments 3 days a week in 12-hour shifts.  My day starts at 4 am & I am…   Read more»

@ljatta I agree with you, the FDA absolutely cannot guarantee anything as evidenced by what is allowed to be called food in America. Not to mention the pharmaceuticals that have been on the market for years just to be taken…   Read more»

@reshamn I completely agree with you. Quality in my opinion can be summed up in one word…Integrity. It’s literally the integrity of your company. Essentially what you do when the customer isn’t looking. The Quality Department of a company must…   Read more»

This where the phrase “Proper Preparation Prevents Poor Performance” comes into play. It is a necessary department to have when Murphy’s Law goes into effect. QA/QC are vital processes in the developmental pipeline and as much as people love to…   Read more»

Nothing is guaranteed and that includes the official stamp of approval from the FDA. Having the FDA approval does lessen the burden of concerns, but it is up to the consumer to do their due diligence in terms of their…   Read more»

The de novo request offers a marketing route to categorize novel medical devices for which general controls or general and special controls offer a reasonable assurance of safety and efficacy for the intended application but for which there is no…   Read more»

The COVID-19 outbreak is one example of a disease outbreak that comes to mind. I believe that the United States should have made better use of data analytics and predictive models to aid in curbing the virus’s spread. Governments and…   Read more»

One of the roles that I see in the space is a quality control manager. I could see myself in this role as there are a lot of pros to working in this position. Quality professionals have access to a…   Read more»

Well, I am not sure that we can prevent any disease outbreak. Any group of animals that live in close proximity to one another are going to cause and outbreak of infection at any point. However, I do believe outbreak…   Read more»

It is the opinion of the writer that based on the information that was provided in Dr. Simon’s presentation on Pre-Clinical Research, most researchers in academia rely more so on grants; meanwhile, individuals who work in the industry setting rely…   Read more»

@ljatta In academia, there is an abundance of projects one can choose from. I agree that not finishing a project would lead to some repercussions and a lack of confidence, but realistically, not all projects will succeed. I would think…   Read more»