Clinical Research Organizations, or CROs, are very beneficial to companies to have certain responsibilities for creating products to be done. With CROs, companies save money as they do not have to worry about expenses for human resources or equipment. CROs will do accordingly to get the research done in a timely manner with their money. In…[Read more]

Completing the simulations throughout the semester helped me learn a lot about working in the industry. Having to go through different rounds to determine the causing factor for an error or to update documents, gave a look into what happens in real life. In addition, it helped to apply what was reviewed in the PowerPoints into possible…[Read more]

When looking into different possible career paths to consider within the Biomedical Engineering field, I have looked in to Clinical Research. I feel that it might be a position I might consider to try out maybe once to see if it is something I would be interested in. I think the profession is very beneficial as a learning experience and helps…[Read more]

A major reason as to why a clinical study may be stopped would be due to a side effect that was not expected. If one of the participants in the study ends up having a side effect, especially one that is life threatening, the study will be shut down to prevent from putting more lives at risk. If there is only a slight side effect, but it occurs…[Read more]

The costs should not be the major determining factor in determining the location as to where clinical trials are held. Organizations should be putting their main focus on as to which location is relevant to their study or would allow for the research to be completed successfully. If they put more emphasis as to which location would be most cost…[Read more]

After taking both the MDD and AMDD courses, the topics that are taught and reviewed within these courses are very beneficial. The courses shine light on processes that have to be followed within the work area and what the different types of positions entail. These courses gave me a better understanding as to what is expected and the knowledge…[Read more]

Companies should not have a choice as whether they have GMP’s or no GMP’s. The GMP lays the foundation for the company with a set of regulations that it needs to follow. This will provide order or organization to how the company functions. With no GMP, the company has no requirements set and it lets everyone do as they please. In addition, if…[Read more]

It is important that companies, no matter how small, should include GMP’s, Good Manufacturing Practices. With GMP’s, a set outline of regulations or requirements is put in place for the company. If there is a startup company that does not have any GMP’s set yet, that does not necessarily mean that the company will fail. This gives the compa…[Read more]

CAPA, Corrective and Preventative Actions, works to fix and improve products based on information gathered. CAPA consists of analyzing information received and classifying any problems. Based on this, certain actions are completed in order to prevent the problem from occurring repeatedly. With CAPA, the best form of the product is created and…[Read more]

An internal audit may find issues in the quality system that the major audit may not have found. However, it would seem that this might not be effective. With an internal audit, the audit is completed by the quality employee working at the company itself. One factor to consider is the fact that the auditor might not be completely honest with…[Read more]

The GMP, or Good Manufacturing Practice, gives a general outline of the requirements set for the company. This includes the methods, facilities, and controls within the project. The methods that are done to complete the project should meet with these set requirements. It would make sense for the company to update the GMP accordingly with the…[Read more]

As previous posts have stated, the decision depends mainly at the situation at the time and the company’s policies. Depending on the stage that the project is at, the project can either be grandfathered with the previous system or if it had to updated for the new changes made. If the project has completed the DHF and Design Transfer, it would s…[Read more]

An essential phase within the product life cycle is the product introduction phase. In this stage, the transition from development to launch takes place. As the product enters the market, it is important to consider the current market value and any competition that is currently in place. This way, the sales team can determine the most effective…[Read more]

Obsolescence of a product is important and plays a major role when product is no longer as popular or successful anymore. The company is wasting their resources and time creating more of these products, when they are not selling at the rate they were initially at release, or sometimes not even selling at all. As others have mentioned as well,…[Read more]

When a company makes a deal with the customer, it is very important that the person making the deal has both interpersonal skills and business knowledge. Business knowledge is a key factor in making a business deal. If the team leader does not have full understanding on their product then the customer will not be as interested. In addition, if…[Read more]