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 topics that are directly related to real-world practices. I believe this class taught in personnel can also be very…[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 its results are the real world. Lastly knowing if the subjects need to undergo an additional procedure as part of the…[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 the circumstances be, any fraud should be dealt with strictly and regulations should be…[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 advantages attract big companies to European and Asian countries.

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 do the heavy lifting. Their developed system would Speedline the process turns of getting the maximum value from the money…[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 catching mistakes on information that could lead to a snowballing effect if done by the FDA or 3rd party.…[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 procedure incident, there was a non-conformity which lead to a CAPA. Depending on the severity and if…[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 is a preventative action in knowing that all documents are procedures are accurate, up to date and follow proper…[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 “defined-term” employees. This means that each full-time employee has a set end date before they are…[Read more]