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

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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
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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

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
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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.

Good Manufacturing Practices for Pharmaceuticals


Good Manufacturing Practices for Pharmaceuticals
  • Author : D. Nally Joseph
  • Publisher : CRC Press
  • Release : 2000-10-12
  • ISBN : 9780824741938
  • Language : En, Es, Fr & De
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Highlighting key issues and differences among GMPs of Europe, Canada, and the WHO, this reference examines US law and governmental policy affecting domestic and multinational pharmaceutical manufacturing. The book recommend pragmatic ways to interpret and comply with FDA CGMP regulation and related criteria. They focus on geographical redistribution of manufacturing facilities, accommodation of a diversity of regulatory and statutory governance, adaptation to disparate human resources, and new growth areas of manufacture and distribution of homeopathic remedies and dietary supplements, in addition to the greater quality control required of pharmacists and other authorized dispensers.

Global Clinical Trials Playbook


Global Clinical Trials Playbook
  • Author : Menghis Bairu
  • Publisher : Academic Press
  • Release : 2012-06-12
  • ISBN : 9780124158603
  • Language : En, Es, Fr & De
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Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios

Pharmaceutical Computer Systems Validation


Pharmaceutical Computer Systems Validation
  • Author : Guy Wingate
  • Publisher : CRC Press
  • Release : 2016-04-19
  • ISBN : 9781420088953
  • Language : En, Es, Fr & De
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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews r