• 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]

  • reshamn replied to the topic CAPA in the forum Quality Systems Management 8 months, 2 weeks ago

    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]

  • 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. However, with the proactive approach, different kinds of corrective actions will prevent the ‘why’ from happening again. We are usually more likely to…[Read more]

  • 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 in each location. If the equipment is being assembled in different location then the results can vary due to errors. Instead of re-validating each…[Read more]

  • I worked in the software development area. Our company would call it the Engineering Change Order for Code Change. There were many change orders depending on whether it was an addition to the code, or enhancement. Sometimes, it would be required to process a change order for even maintenance especially if it would be server maintenance. I remember…[Read more]

  • The change process is really when someone identifies an issue that may need to be addressed. In agreement to the post above, there is a cost factor added to any kind of ECO. Therefore, an ECO is reviewed very carefully before signing off since there are many factors attached to it. I worked in the software development side and our client need some…[Read more]

  • SOP is basically a step by step instructions document compiled so that the workers can carry out a complex routine efficiently. I definitely think the SOP’s should be written during research phase. In fact, I used to intern at a lab where we were researching on stem cells. Obviously, the very first time if you are running a procedure it will have…[Read more]

  • A follow-up question from Dr. Simon’s post:

    As I mentioned earlier, once the DHF is sealed any ongoing changes should be added to the DMR seems more logical to me.

    For those of you who are currently working in the medical device industry or have had previous experience with this, which of those two thoughts does your company follow? Is one…[Read more]

  • The DHF is a simply the collection of documents from the design to the development process. It is key file that contains all the design controls documentation and therefore it is a requirement by the FDA for the 510k submission. A technical file is very similar version to a DHF except that is a European version for the 510k. The technical file…[Read more]

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