Intention to create legal relations essentially means that both parties are agreeing to enter a legally binding contract. This is obviously important ...

I enjoyed seeing the comparisons between a career in academia vs. a career in industry. I currently work in industry, but it was neat to see the pros....

I think it's important to discuss the responsibilities of the consulting firm in the agreement and ensure that all expectations are crystal clear. Of ...

I do not work in medical device industry but our company holds risk assessment meetings for any type of change (change control) or new project coming ...

Hypothetically, if you have a project team who is really pushing to get their product on the market or are pressured by deadlines in industry, having ...

I don't have experience using Gantt charts myself in my current career but I have worked with engineers/project managers that use Gantt charts for the...

For me, I am most interested in the planning, verification and validation process. I think the verification and validation steps are where you do the ...

I believe companies do all sorts of analyses to understand what the best approach is to adhere to the standards posed in ISO 13485 and 21 CFR 820:30, ...

One example of a product that probably we have all seen before that would have a design specifications document is an otoscope. An otoscope is a tool ...

I do not currently work at a medical device company but I work a cosmetic manufacturing plant that employs roles in QA, QC, and project managers that ...

I think one of the most common careers where GCP is involved is "Clinical Research Associate". I think this has come to mean in general, someone who i...

While the two areas are very different and deal with different scenarios, I think the information exchange between the two departments needs to be ver...