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 one of the only classes that have…   Read more»

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 determining the class because…   Read more»

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 could be of various types and due to various reasons. Whatever…   Read more»

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 patients, good data quality, and GCP compliant activities. These…   Read more»

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 hiring an outside company to…   Read more»

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 improvements are actually viable. Another is…   Read more»

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 salvageable but it can be scrapped. However, in a…   Read more»

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 with a fine tooth comb. Doing so…   Read more»

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 seems to be getting more popular is hiring many…   Read more»

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 that is…   Read more»

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, of procedures. It can also be a tool…   Read more»

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 other alternative solution to what said…   Read more»

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 phase needs ample testing and qualification which…   Read more»

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. Products that have shown a decline…   Read more»

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 will be executed effectively. The…   Read more»

In my experience, I believe that staying informed about the industry is one of the most important aspects. The first and biggest reason is knowing your competition how one can make sure that our product is best in its market….   Read more»

In my experience, the leadership and their motivation have been the biggest hurdle for the innovation and research for the company I work for. My company produces products that are widely used and very successful in their niche. This has…   Read more»

Efficient and proper validation is key for proper functionality. The validation I have seen that very key in certain institutions are testing of every component in terms of material/functional validation, leak functionality, various chemical coating functionality and shelf life. The…   Read more»

I agree with your justification but to take a step further, I believe the reevaluation should be done as often as possible. Granted a full reevaluation can be costly and unnecessary but it can be preventative for future issues. Just…   Read more»

I very much agree with your statement. Internal audits are essential for keeping an up to date quality system. Implementing CAPA as a result of internal audits issues will help keep the company out of trouble. If for example, a…   Read more»