Ruiz, Eileen, PhD

Quality Assurance: Role of the Quality Assurance Professional in the Manufacturing of Medical Products - Understanding the Life Sciences Industry Ruiz, Eileen, PhD

Quality Assurance: The Role of the Quality Assurance (QA) Professional in The Manufacture of Medical Products, presents an introduction to the role of the QA personnel in the biomedical industry, focused on the manufacture of pharmaceuticals and medical devices. The content is intended for those interested to work in the Industry and seek guidance about employment alternatives. The book provides an introduction of the organizational structure and dynamics of working in a regulated manufacturing environment, under quality systems. In general, we present the important elements you need to know about the quality role in the industry. You will gain basic knowledge about quality, quality systems, quality audits, and how to handle non-compliance events. You will also have an overview of the business and regulatory aspects of the sector.