How to Build and Maintain an Effective Pharmaceutical Quality Management System Books

Click Get Book Button To Download or read online How to Build and Maintain an Effective Pharmaceutical Quality Management System books, Available in PDF, ePub, Tuebl and Kindle. This site is like a library, Use search box in the widget to get ebook that you want.

How to Build and Maintain an Effective Pharmaceutical Quality Management System


How to Build and Maintain an Effective Pharmaceutical Quality Management System
  • Author : Ajaz S. Hussain
  • Publisher : Academic Press
  • Release : 2018-06
  • ISBN : 0128140461
  • Language : En, Es, Fr & De
GET BOOK

How to Build and Maintain an Effective Pharmaceutical Quality Management System shares unique insights on how to improve our understanding of the human factors regarding 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 improve understanding of QMS, particularly focusing on the essential role of human factors using 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

Medical Device Quality Management Systems


Medical Device Quality Management Systems
  • Author : Susanne Manz
  • Publisher : Academic Press
  • Release : 2018-10
  • ISBN : 0128142219
  • Language : En, Es, Fr & De
GET BOOK

Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans

Good Design Practices for GMP Pharmaceutical Facilities Second Edition


Good Design Practices for GMP Pharmaceutical Facilities  Second Edition
  • Author : Terry Jacobs
  • Publisher : CRC Press
  • Release : 2016-08-18
  • ISBN : 9781315355023
  • Language : En, Es, Fr & De
GET BOOK

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

The Deming Management Method


The Deming Management Method
  • Author : Mary Walton
  • Publisher : Management Books 2000
  • Release : 1992
  • ISBN : 1852521414
  • Language : En, Es, Fr & De
GET BOOK

Whether you are the owner of your own small business, a middle manager in a mid-sized company, or the CEO of a multinational, this book aims to show you how to improve your profits and productivity, following the principles of the Deming management method.

Building Quality Management Systems


Building Quality Management Systems
  • Author : Luis Rocha-Lona
  • Publisher : CRC Press
  • Release : 2013-06-25
  • ISBN : 9781466565005
  • Language : En, Es, Fr & De
GET BOOK

Quality has quickly become one of the most important decision-making factors for consumers. And although organizations invest considerable resources into building the right quality management systems (QMSs), in many instances, the adoption of such quality improvement tools are just not enough. Building Quality Management Systems: Selecting the Right Methods and Tools explains exactly what directors, practitioners, consultants, and researchers must do to make better choices in the design, implementation, and improvement of their QMSs. Based on the authors’ decades of industrial experience working on business improvement projects for multinationals looking to design or improve their QMSs, the book discusses building QMSs based on two important organizational elements: needs and resources. It begins with an overview of QMSs and systems thinking and the impact of QMSs on financial performance. Illustrating the process management approach, it reviews the most well-known business and quality improvement models, methods, and tools that support a major QMS. The authors introduce their own time-tested methodology for designing, implementing, and enhancing your own QMS. Using their proven method, you will learn how to: Implement a strategic quality plan based on your specific needs, capabilities, cost–benefits, policies, and business strategies Select the right models, methods, and tools to be adopted as part of your QMS Understand the critical success factors and implementation challenges Evaluate the level of maturity of your QMS and your implementation efforts Highlighting the importance of quality as a way of life, this book supplies the understanding you’ll need to make the right choices in the development and deployment of your QMS. With a clear focus on business performance and process management, it provides the basis for creating the quality management culture required to become a world-class organization.