hm243

Forum Replies Created

RE: CROs

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 wo...

In forum Clinical Trials for Medical Devices

7 years ago
RE: Simulation Experience

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...

In forum Clinical Trials for Medical Devices

7 years ago
RE: career path

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 tr...

In forum Clinical Trials for Medical Devices

7 years ago
RE: Unexpected Clinical Study Results

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...

In forum Clinical Trials for Medical Devices

7 years ago
RE: Clinical Study Location/cost vs. results

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 rele...

In forum Clinical Trials for Medical Devices

7 years ago
RE: AMDD

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 ...

In forum Clinical Trials for Medical Devices

7 years ago
RE: No GMPs

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 o...

In forum Quality Systems Management

7 years ago
RE: Discussion Topic: Vagueness of GMP's

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 ...

In forum Quality Systems Management

7 years ago
RE: CAPA

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 thi...

In forum Quality Systems Management

7 years ago
RE: Audits

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 complet...

In forum Quality Systems Management

7 years ago
RE: Improving GMPs

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...

In forum Quality Systems Management

7 years ago
RE: Discussion Topic: When Quality Systems change in the middle of a project

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 grandfathe...

In forum Quality Systems Management

7 years ago
RE: Discussion Topic: Managing the Product Life Cycle

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 impo...

In forum Product Life Cycle and Product Management

7 years ago
RE: Product Obsolescence

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 produc...

In forum Product Life Cycle and Product Management

7 years ago
RE: Interpersonal Skills

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 ...

In forum Product Life Cycle and Product Management

7 years ago
Page 1 / 6