Clinical trials do have risks and downsides involved, and thus, this can result in a clinical study being shut down. Unscheduled inspection by FDA sta...
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 mar...
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-sav...
Hi Fady! Unfortunately, companies are constantly under budget restrictions, and sometimes this leads to an entire department to go through a hiring f...
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 ...
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 r...
GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that pr...
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,...
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 r...
Hi Dr. Simon! The heart of validating a process is ensuring it is installed to specification, while characterized and optimized to be under control a...
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 argu...
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 ma...
Hi Luisa, I certainly think that SOPs should be required during the research phase. SOPs help define the department’s standard practices and daily pr...
Hello! To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might...
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 requi...