Nowadays, most people are entering for a clinical trial that involves a cancer immunotherapy but they are at an advanced stage of the disease. Recently, there have been deaths related to this kind of ...

CAR-T therapy is an upcoming cellular therapy to treat cancer. It has been recently shown to be successful with ALL patients. However, this wasn't the case in July 2016 Leukemia CAR-T trials. Three ad...

There are major differences in a SR vs. NSR studies. A SR needs to submit an IDE and must follows all regulations associated with it in 21 CFR 812. They also need that IDE approved before they can pro...

An effective internal auditing takes a progressive, forward-looking mindset that helps people point out problems before they arise. By doing an audit, a company can understand how activities and proce...

Smaller organizations and even entrepreneurs can perform internal audits or sometimes they even have it performed by someone in an efficient and cost-effective way. This way it produces positive chang...

There are both pro and cons to GMP. The major pro is that it assures that the identity, quality and the purity of the product is legitimate and that it requires manufacturers by abide by strongly. But...

A CAPA process that I was a part of during my exposure in the IT industry. Although, the term CAPA wasn't used but the process was similar. There was a defect in running our energy scripts in the soft...

I would also like to touch upon the importance of CAPA. CAPA is extremely essential in the manufacturing area. It gives the early benefit of identifying current and potential issues in a product befor...

Sometimes, presenting numbers isn't the effective way to communicate the need for more resources, for instance budget. By taking the focus away from numbers, one can present how the objective meets th...

While all are important to be a successful product manager, there was another aspect that I came across during my research. One of the most important characteristics of a great PM is their relationshi...

If the company is high in the tech arena, then their products can out date in relatively short amount of period. Sometimes, components for older products need to comply with new standards or requireme...

Along with the posts above, assuming there is funding available and a separate group to drive the innovation, there is always the problem the innovation being brought up in a wrong time. It could be a...

Thanks for bringing up a great point. As an undergraduate, I was required to take a technical writing course but sadly enough, that course was very similar to any other Humanities course. The closest ...

In agreement with the post above that it is more beneficial to be proactive than reactive. In the reactive approach, a root cause analysis is usually performed to answer 'why' a problem exists. Howeve...

I agree with the post above that it can be tedious and time consuming to re-validate all processes. However, the process is very critical to make sure that the equipment is producing the same results ...