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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   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…   Read more»

Of all the phases involved in the product life cycle, as others have stated, the planning and development stage would seem to be the most expensive. During this stage in the product life cycle, the company is constantly working to…   Read more»

This is a very interesting topic to bring up. If the market does not seem appealing or in bad condition, then it would make sense for the company to decide to stop production. However, this could also, hurt them as…   Read more»

The product manager is in charge of a specific product being released and follows through the product’s life cycle. The product manager is in charge of making sure the product is successfully built and launched into the market. As others…   Read more»

This is a very interesting factor to point out. Validation deals more with the process of ensuring that the customer’s needs are met. Verification focuses on making sure that the parts involved in creating the product are correct. The validation…   Read more»

In a situation like this, it is primarily important to determine the factor that caused the failure. Once the reason for failure is found, then measures can be taken to fix the issue and possibly prevent the failure from occurring…   Read more»