As we read the news around the world it almost seems that there is some sort of natural disaster occurring.  Hurricanes, monsoons, earthquakes are occurring around the world and when they do they have an […]

ISO 13485 is an internationally recognized quality management standard for organizations involved in the development, manufacture and distribution of medical devices. The standard was first published in 1996.  It was updated in 2003 and again […]

Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply chain. Especially in regulated environments, QAs form a crucial part of the supplier qualification process. […]

Quality Elements for Suppliers of Products or Services to GMP Regulated Companies outlines the basic GMP elements expected of suppliers whose products or services eventually enter the supply chain for commercial manufacturing and delivery of […]