I agree with the comments above that costs are a major consideration when outsourcing clinical trials. When there is a discussion about cheaper costs in other countries, there is also a concern about ...

I think all undergraduate and graduate programs should considering adding courses like this because it gives students a glimpse of what it is like in the industry. My first job out of college as a R&a...

A couple of weeks ago my company had to place product on hold and initiate a CAPA because of nonconforming product. At a high level, a custom component from a supplier was not made to specification an...

In addition to internal audits to improve quality, my company also hosts internal kaizen trainings for various process to make continuous improvements. I have never heard of a kaizen until I joined th...

From my experience in the industry, this is a common problem in many departments. I’ve seen departments over loaded with work and the quality of the work that they are able to accomplish decreases. So...

The FDA anticipates publishing a proposed rule early in 2019 on aligning the two. The FDA was instrumental in the revision of ISO 13485, most of the Part 820 regulation requirements are covered in ISO...

My company performs a yearly review of our manufacturing practices. However, I did find a publication by the NSF about changing your quality culture and improving GMP behaviors. It steps the reader th...

I think it can get tricky when talking about process revalidation and what is required to qualify the equipment to be used in the process. In my opinion, I don’t think you would need to revalidate the...

I think we can all agree that it is better to be proactive in MOST, if not all situations for the best interest of the business. I think it is also important to note that by definition one of the inte...

I feel that my undergraduate career prepared me to write technical reports more than protocols. I am confident in my writing abilities, however, I still feel like it is always a good idea to get an in...

I think a SOP should be used during the research phase but if not, I think it MUST be used during development. This way the engineers would be able have some sort of traceability to know that the proc...

In my experience, I add as much detail as possible to SOPs such that there is no room for interpretation because our processes are so tightly controlled. For example, right now I am developing a proce...

I currently work as a manufacturing engineer at a medical device company. My team is responsible for maintaining the on market device. We use DCPs (Design Change Process) to make any changes to the de...

My company doesn’t fill out a DSD. However, we do maintain a traceability matrix that shows all of the verification and validation activities completed for each design input. I think the level of up f...

I currently work in manufacturing and I see a lot of instances when a design and process needs some form of verification or validation. We use verification activities to test and confirm that product ...