The type of clinical trial my group is involved with is a prospective clinical study which is collecting data in real time. We are 20 locations that e...
I'm not positive why a clinical trial would be shut down, but if I had to guess I'm sure it would be due to some unethical situation or if someone bro...
In the current company I work for, I could potentially see myself working in Clinical Development (basically the same as clinical research). I would b...
Since the quality department can't perform their own audits and internal audits are necessary for companies to find and mediate risks in their quality...
Good manufacturing practices (GPM) are quality regulations that medical/pharmaceutical companies follow in order to reduce the risk when producing med...
Pros of internal audit: 1. Improve efficiency in operations 2. Ensure compliance with laws and statutory regulations 3. Risk assessment 4. Provide...
While I do not have experience as a project manager I do believe that all roles are equally as important, but if I had to pick one in which I believe ...
My company is all about funding the R&D department and pushing for innovation but while they are willing to fund the R&D department in complet...
I believe the companies main priority is to produce a device that will help the company profit, and we know that this isn't always the case. If a comp...
Technical writing is extremely important in industry, but unfortunately, during my time as an undergrad at NJIT, I was not exposed to any technical wr...
The quality of your writing style should create a similar impression on the quality of the work being performed. When writing or re-writing an SOP you...
ECO’s (Engineering Change Orders) are used for changes in components, assemblies, or documents such as processes and work instructions. I have not fi...
Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. I do b...
I believe the design history file (DHF) is more useful because it is a compilation of documentation that describes the design history of the medical d...
I believe that deciding between a re-executing full verification and validation protocols or conducting a regression test depends on the situation. In...