How to Build and Maintain an Effective Pharmaceutical Quality Management System

How to Build and Maintain an Effective Pharmaceutical Quality Management System shares unique insights on how to improve our understanding of human factors in pharmaceutical quality. It describes practical ways to improve systems thinking and ways to establish effective quality management systems. Insights are derived from the author's experience at the US Federal Drug Administration (FDA) and as a leader of the FDA's PAT and 21st Century Initiatives, and finally, as an industry executive. The book describes the fundamental concepts and explains how to understand QMS, particularly focusing on the essential role of human factors that are illustrated through real-life examples.

• Utilizes explicit case studies to illustrate ideas throughout the content
• Emphasizes three key areas, including management, supervisors and staff
• Written by a leader in the field with experience in regulatory, research and technical areas