I very much appreciate this class. As especially because before I worked in the industry my notion were completely incorrect. After starting to working in the industry I realized that this class is on...

The biggest determinants for the classification are one the basis for the risk determination. The second, the nature of the harm that may result from the use of the device, this is the biggest key in ...

Good clinical practice is a guideline for conduct of clinical research. Even though these guidelines are available misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud co...

More and more companies are outsourcing their clinical trials due to the advantages in cost efficiency. But that isn't the only advantage. The countries are able to provide fast recruitment of patient...

The biggest advantage to in hiring CRO is the expertise and experience that the company would provide. Do to their sole role in the industry. And the second biggest would be its cost efficiency of hir...

There is a big advantage of besides being prepared. As an employee involved in improving and auditing the company's procedures, there is a double insight that can help the audit in seeing if the impro...

Usually, non-conformities occur during the production process but from what I have experienced it is usually a minute error by a production worker on the production line. Usually, the product is salva...

Something that my company did and is currently doing to improve GMP is overhauling a remediation that looks over every procedure and important documents used in the management system and going over it...

This situation is evident in smaller companies. Auditing your own work defeats the purpose this is why private auditing firms are hired to access the companies process. However, another practice that ...

In layman terms, the biggest difference is that a Corrective is immediate fix and is more of a one time or a defect of a process. Whereas a corrective action is a method of solving a reoccurring issue...

Besides being a document, a CAPA is multiple phases that a company goes through the implement what the CAPA is stating. Overall it has an identification, evaluation, and investigation of a deviation,...

During the maturity, stage sales will plateau, and the profit margins of your products will begin to decline. This is typically caused by a number of factors come this can be market saturation or othe...

The most expensive phase I believe is the development phase and only slight lead to the introduction phase. The development phase takes the most resources when It comes to new flagship products. The p...

A procedure that I have noticed that has seemed to work is market research on each product line the company offers. The research is presented to of concern departments and an assessment is taken. Prod...

A person business and technical acumen are very important in term of relation to deals. Each party is taking a risk for each other to work together, and the knowledge provides confidence that the deal...