Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA staff can uncover not-so-good manufacturing practices...

Recently, I was involved in a single blind user study at work that involved our production parts and an R&D part that will be available on the market within the next year or two. As Dr. Simon ment...

The cost of conducting a clinical study has increased over the years, and thus, this rapid increase has led to companies’ growing interest in cost-saving strategies. That being said, I agree with neb2...

Hi Fady! Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring freeze or a travel freeze. Although new engineering ...

Hi All, I would also like to agree with all of the responses above. To put it in simpler terms, Corrective Action is based on a nonconformance event that has happened in the past, and Preventative Act...

Great question! Gh56 goes into wonderful detail about the pros and cons of conducting an internal audit and I’m sure all students can agree with his response. From the time that I started working at t...

GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that produce the devices must have procedures to comply w...

I agree with other students’ input in regards to companies choosing to not have GMP. GMPs typically cause companies to invest in a large sum of money, and to go through the hassle of understanding the...

Yes, I do believe that the GMP’s ambiguity does make it a lot more difficult for startup companies that do not have an existing framework of general requirements to follow. The ambiguity allows for de...

Hi Dr. Simon! The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control and capable of consistently meeting specifications. ...

If the equipment gets moved from one location to another, I do not believe that all processes have to be revalidated. The reason the quality team argued that is because if the equipment was assembled ...

Hi Chris! The ideas of the holistic engineer embodies the point of view than an engineer needs to consider the whole system, the body of work that makes a product successful. The engineer participates...

Hi Luisa, I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily processes conducted to assure execution of research t...

Hello! To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might be necessary to respond to safety issues, market d...

The FDA uses post-market surveillance to monitor the safety and effectiveness of medical devices once they are on the market. It is a regulatory requirement and a system that provides continuous feedb...