Why so many pharmaceutical companies are struggling to meet GMP and other regulatory requirements? The reason is clear: because they are trying to improve their quality management systems by fixing symptoms rather than by attacking the fundamental and primary root cause of their problems which is the lack of adequate quality and compliance culture. The purpose of this book is to provide those leaders and senior managers with a clear roadmap to solve their regulatory problems and to return to the route of compliance by implementing a strong, positive quality and compliance culture. The recipe is simple: all you need is good people (including good leaders and senior managers), good procedures and good training programs sailing into a strong and positive culture of quality and compliance. When a company implements a behavior-based quality and culture compliance, they look into their problems as a whole, and they understand that there are multiple factors (including the soft ones related to personal and organizational behaviors) that affect performance. A very positive consequence of this systematic thinking is the shift from CAPA programs mostly correctives to ones where the systemic preventive actions are predominant. Quality is everyone’s responsibility, but when it comes to creating, strengthening, or maintaining a culture within an organization, there is one group who really owns it: the leaders and senior managers. The good news is that creating or strengthening a positive and sustainable quality culture is an achievable task although not an easy or quick one. In this book you will find ten foundational principles of a strong and positive quality culture, their associated desired behaviors and a set of leading indicators that can be used to monitor and enhance leadership engagement, people engagement, and culture and maturity.
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Zustand: Very Good. : Este libro aborda la problemática de las empresas farmacéuticas que luchan por cumplir con las normativas GMP y otros requisitos regulatorios. El autor sostiene que el problema fundamental no radica en los sistemas de gestión, sino en la falta de una cultura de calidad y cumplimiento adecuada. A través de sus páginas, se ofrece una hoja de ruta clara para que líderes y directivos implementen una cultura basada en el comportamiento, transformando los programas correctivos en acciones preventivas sistémicas.La obra presenta diez principios fundamentales para establecer una cultura de calidad sólida y positiva, detallando los comportamientos deseados y los indicadores clave para monitorear el compromiso del liderazgo y la madurez organizacional. Es una guía esencial para entender que la calidad es responsabilidad de todos, pero su sostenibilidad depende directamente de la dirección de la empresa. EAN: 9781736742907 Tipo: Libros Categoría: Negocios y Economía Título: Quality Culture in the Pharmaceutical Industry Autor: Jose Rodríguez-Pérez Editorial: Business Excellence Consulting Idioma: en Páginas: 214 Formato: tapa blanda. Bestandsnummer des Verkäufers Happ-2026-04-14-b531e59c
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