New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating […]

FDA Requirements for ensuring Premarketing Clinical Trial Safety

The FDA has set out requirements for sponsors and organizations that carry out clinical trial to ensure premarketing clinical trial safety. This is a very vital requirement because this is the stage at which the database that goes into clinical trials is formed. Its integrity and safety is an important ingredient for assessing the risks […]

The impact of effective complaint handling on quality system

Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling […]