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 mos...

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 ...

These simulations definitely helped understand the topics we learned during class. I believe the last simulation we are currently working on is the mo...

As the person above provided examples, an easier way to observe the difference between significant risk medical devices and non significant risk devic...

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 tak...

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 co...

As mentioned above, usually corrections and CAPAs go hand in hand. Corrections are immediately done to eliminate the non-conformity in real time. Whil...

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 a...

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 sta...

As the others have mentioned, if there were no GMPs I believe most companies would not follow the guidelines set forth for good manufacturing processe...

As others have mentioned, the development phase is the most expensive due to the time and effort from the design generation stage. Additionally, durin...

I believe the product manager has many roles which include, identifying profitable opportunities that meet market needs, launch products into the mark...

I agree with the comments above where a successful team leader should have good interpersonal skills. It is essential for the leader to additionally h...