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 trial and have put researchers on edge because they don’t understand as to why was there a reaction. There are autoinflammatory responses that they…[Read more]

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 adult leukemia patients died in a trial of a new cellular-level medicine, CAR-T. Patients experienced cerebral edema. The sponsoring medical…[Read more]

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 proceed with the study. However, for a NSR, the IDE application does not need to be approved by the FDA. However, it needs to follow the abbreviated…[Read more]

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 processes are operating and always looking for ways to improve it. It also allows to dwell into know problem areas and develop an action plan to make…[Read more]

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 change and results. It can improve the overall business, the practices and its underlying processes. In some cases, contrary to popular opinion, it may…[Read more]

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 the downside of this is that in order to achieve those point, a robust quality system, a strong strong supply chain management and risk mitigation…[Read more]

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 software called Powerplant. The scripts usually come from a vendor that would be software enhancements or adding employee data. As a contracting company,…[Read more]

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 before it goes into production or as early as possible. Since, it is more costly to the company when a quality issue arises after reaches the customer.…[Read more]

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 the company goals. You can even sometimes link it to their mission or vision. This way the budget can be presented in a broader context and may strike…[Read more]

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 relationship management skills. This is a very important quality since building authentic and trustworthy connections with both internal and external…[Read more]

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 requirements. If the sales for that product is already decreasing, then the company may not invest more time, money and man hours on updating the necessary…[Read more]

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 novel and achievable idea but maybe the market isn’t just ready for it. If the idea is too early upon its time, then team can probably study trends…[Read more]

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 exposure to technical writing was provided by the Capstone course. But now going through the part 1 of this MDD course, I have come across many…[Read more]