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Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636940129
Category : Business & Economics
Languages : en
Pages : 152
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Book Description
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636940129
Category : Business & Economics
Languages : en
Pages : 152
Get Book Here
Book Description
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
Author: James B. Shore
Publisher: Quality Press
ISBN: 0873899318
Category : Business & Economics
Languages : en
Pages : 108
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Book Description
In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect. The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors. In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world. Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether its a requirement or a tool to help achieve compliance. The Lessons from the Road icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.
Author: Richard Whelan
Publisher: U of Nebraska Press
ISBN: 9780803297609
Category : Photography
Languages : en
Pages : 380
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Book Description
The legendary war photographer Robert Capa carried into his personal life the same remarkable vitality that characterizes his pictures. Driven from his native Hungary by political oppression, he was first recognized for photographing the Spanish Civil War. In 1938 he was in China recording the Japanese invasion. During World War II he was in London, North Africa, and Italy, and then in France covering D-Day on Omaha Beach, the liberation of Paris, and the Battle of the Bulge. When the new nation of Israel was founded in 1948 he was there. In 1954 he was in Vietnam, taking photographs until the moment he was killed. Away from battle, Capa gather about him such famous people as Ernest Hemingway and his wife (the war correspondent Martha Gellhorn), Gary Cooper, Irwin Shaw, and Gene Kelly. Whelan shows Capa photographing the street life of Paris, crisscrossing America on assignment from Life, in Russia with John Steinbeck, in Italy with John Huston, on the Riviera with Picasso, and with Ingrid Bergman.
Author: Susanne Manz
Publisher: Academic Press
ISBN: 0128142227
Category : Science
Languages : en
Pages : 298
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Book Description
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
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: Abraham Clark Freeman
Publisher:
ISBN:
Category : Law reports, digests, etc
Languages : en
Pages : 1038
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Book Description
Author:
Publisher:
ISBN:
Category : Law reports, digests, etc
Languages : en
Pages : 1040
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Author: Robert B. Denhardt
Publisher: CQ Press
ISBN: 1506382673
Category : Political Science
Languages : en
Pages : 569
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Book Description
Managing Human Behavior in Public and Nonprofit Organizations, Fifth Edition is an established core text designed to help you develop your leadership and management skills. Bestselling authors Denhardt, Denhardt, Aristigueta, and Rawlings cover important topics such as stress, decision-making, motivation, leadership, teams, communication, and change. Cases, self-assessment exercises, and numerous examples provide you with the opportunity to apply concepts and theories discussed in the chapter. Focusing exclusively on organizational behavior in both public and nonprofit organizations, this text is a must-read for students in public administration programs. New to the Fifth Edition: Increased attention to issues related to nonprofit organizations helps you develop a better understanding of the differences and similarities in public and nonprofit organizations, as well as the way they interact with one another and with the private sector. Broadened coverage of issues related to ethics and diversity offers you a broader perspective on important issues to consider, such as the examination of implicit and explicit bias, generational differences, and power and privilege. Additional discussions of collaboration, inclusion, and participation, both within the organization and with external constituencies, show you the value rationale for engagement and its practical effects. Revised and updated information on emerging technology illustrates to you how an increasingly digital, connected, and networked environment affects our ability to manage public and nonprofit organizations. New cases, examples, self-assessments, and exercises cover recent developments in research and practice to offer relevant ways for you to practice and improve your management skills.
Author:
Publisher:
ISBN:
Category : Electronic journals
Languages : en
Pages : 574
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Author:
Publisher:
ISBN:
Category : Engineering
Languages : en
Pages : 872
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Book Description
