It is an absolute necessity to improve the relationship of QC with other company departments. It is in fact in those other departments best interest to ensure a healthy relationship with their QC. The...

I don't believe companies intentionally want to fail to adhere to the rules. With the analogy of the speed ticket, for instance, let say you are rushing to get somewhere and unfortunately get pulled o...

When the De Novo process was first initiated, sponsors needed to submit the premarket notification (510(k)), to which the FDA would issue final 510(k) decision of “not substantially equivalent” due ...

An example of FDA approved wireless medical devices is the wireless electrocardiogram. It consists of the ECG monitoring circuit, microcontroller circuit, and an Android mobile phone. The phone has a...

Combination product: metered dose inhalers, MDIs An MDI is made up of a pressurized canister containing a drug substance and possibly excipients formulated with a propellant. The formulation is aeroso...

While I find it interesting that the standard for labeling is inverted between Sweeden and the US, I am not a bit surprised that the US opted to have the genetically modified goods be " standard". I t...

Although I believe animal testing is clearly unethical, I do find the efficacy of their results extremely valuable. Animal testing has been the most accurate and reliable strategy for checking new dru...

As others students stated, referencing the Toxicity Table from ISO 10993 should give a general idea of tests needed prior to clinical trial phase. Ultimately the test needed will depend on the expect...

Research is always important no matter if it is in Industry or Academia. As Dr. Simon mentioned research in Industry is usually to create a solution to a problem while Academia researches tend to fo...

Before considering if Industry research is " successful" , we need to define what " success" actually is. What parameters are we using to measure success? is it in term of achieving an end result wit...

I think all these three features of a project are all intertwined. Although the achievable seems to stand as the most important one, in reality, it will be greatly undermined if the other two characte...

Besides having a solid technical background that most people are suggesting, I believe a manager should have excellent communication and people skills. We can't really coordinate a project if you don'...

I think no single phase is more important the others because the end project results in the efficiency of all the phase combined. However, I think the initiation phase should be given ample considerat...

One project in which I encountered crucial setbacks was my capstone project assigned to a group of five. We had a year to submit and present our findings. Although we did have an elaborate planning, a...

I strongly believe that, prior to execution of any projects, several rounds of planning and review of milestone should be conducted. The project manager should take into consideration possible delays ...