As others have mentioned, if adverse side effects are observed after the product was used/administered by a patient during a clinical trial, it is most likely paused until effects go away and a soluti...

With my current experience working in the industry, taking part in clinical trials can be a very daunting task with quite a lot of paperwork. Finding a statistical significance can vary from 500 patie...

These simulations definitely helped understand the topics we learned during class. I believe the last simulation we are currently working on is the most realistic where it can apply to a real life exp...

As the person above provided examples, an easier way to observe the difference between significant risk medical devices and non significant risk devices is looking at the classification which is defin...

As Dr. Simon mentioned in his lecture there are different types of clinical studies. This includes prospective clinical study which is collecting data in real time or retrospective which is using old ...

If a CRO is not able to deliver the expected results I am sure there is language within the contract specifying this possible outcome and steps to take to get a proper return on their money and resour...

From my experience with a CAPA usually an ER is filled out with the non-conformity which initiates the CAPA process. An example that occurred in my company was a minor one but there was a labeling iss...

As mentioned above, usually corrections and CAPAs go hand in hand. Corrections are immediately done to eliminate the non-conformity in real time. While CAPA's, are steps taken to find the root cause o...

From my experience with dealing with internal audits, the purpose of it is to prepare the company from a major audit that would occur by the FDA. It allows the company to do a thorough search to find ...

As Dr. Simon mentioned, GMP guidelines are written generally and ambiguously, so how often are companies looking to improve/update their GMP requirements? For those in the work field can you give an e...

I believe in general as a company starts to focus on new processes or focuses on a new project there will always be a learning curve. However, for start up companies due to their size, for the most pa...

As the others have mentioned, if there were no GMPs I believe most companies would not follow the guidelines set forth for good manufacturing processes mainly due to the money. Focusing on following s...

As others have mentioned, the development phase is the most expensive due to the time and effort from the design generation stage. Additionally, during the development phase, any pre-clinicial trials ...

I believe the product manager has many roles which include, identifying profitable opportunities that meet market needs, launch products into the market, oversee products already in the market, and wi...

I agree with the comments above where a successful team leader should have good interpersonal skills. It is essential for the leader to additionally have knowledge of the market place, costs of compet...