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

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. vs cons. of each side and it really opened up my ...

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 course, in a confidentiality agreement there is in...

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 to our plant - typically we conduct a meeting usin...

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 them also be the risk management team can be non-i...

In this week's lecture, we learned about risk analysis/evaluation and how a risk assessment is created for a project. A project team uses this risk assessment in order to tackle the risks of a project...

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 workflow of their project. I think one factor tha...

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 check on "was my planning good?" It serves as a wa...

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, depending on project timeline and difficulty/risk ...

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 that allows doctors to see inside the ear canal, t...

In this week's lecture we learned that validation is making sure the product will meet the proposed user needs/inputs. If something doesn't pass, there are options on next steps. The specifications of...

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 perform similar duties to the ones that were talke...

In lecture this week, we learned about the different roles one can have within Clinical Research, such as a CRA, Data Manager, or Project Leader. Which role do you think would suit you best for your e...

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 is part of a clinical research team that assists wi...

While the two areas are very different and deal with different scenarios, I think the information exchange between the two departments needs to be very solid to ensure the company is prioritizing the ...