How to Build and Maintain an Effective Pharmaceutical Quality Management System

How to Build and Maintain and Effective Pharmaceutical Quality Management System shares unique insights on ways to improve understanding of human factors in decisions on pharmaceutical quality. It describes practical ways to improve systems thinking and to establish effective quality management systems. Insights are derived from the author's experience at the US Federal Drug Administration (FDA), as a leader of the FDA's PAT & 21st Century Initiatives, as an industry executive, and as an advisor and educator on improving the organizational culture of pharmaceutical quality. Organized into three clear sections, How to Build and Maintain and Effective Pharmaceutical Quality Management System describes the fundamental concepts and explains how to improve understanding of QMS, particularly focusing on the essential role of human factors using real-life examples. This book will be essential reading for those involved in pharmaceutical and regulatory organizations, from technicians to senior management. Utilizes explicit case studies to illustrate ideas throughout the contentEmphasis placed on three cohorts - Management, Supervisors, and Staff - providing unique insights for each groupWritten by a leader in the field with experience in regulatory, research, and technical areas INDICE: Section I: Why pharmaceutical quality assurance is prone to frequent failures? 1. Introduction to pharmaceutical quality in the context of therapeutic outcomes 2. Pharmaceutical quality failures in the 20th century 3. Progress and challenges in moving towards the desired state of pharmaceutical quality in the 21st century 4. Human factors, biases, and blind-spots and science and technology gaps Section II: What is the 21st Century Pharmaceutical Quality?  5. A new, higher, level of quality assurance 6. 21st pharmaceutical quality, 21st Cures Act & Manufacturing USA 7. Case Example: QMS Considerations for successful launch of a complex generic product Section III: How to build and maintain an effective Pharmaceutical QMS 8. Remediating an existing QMS: After negative regulatory outcome 9. Effectiveness Assessment of an Existing QMS: Preventing a negative regulatory outcome 10. Ceasing dependence on external regulators: Culture of Quality

• ISBN: 978-0-12-814046-8
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 315
• Fecha Publicación: 01/05/2018
• Nº Volúmenes: 1
• Idioma: Inglés