The Fda And Worldwide Current Good Manufacturing Practices And Quality System Requirements Guidebook For Finished Pharmaceuticals
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The Fda And Worldwide Current Good Manufacturing Practices And Quality System Requirements Guidebook For Finished Pharmaceuticals
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Author : José Rodríguez-Pérez
language : en
Publisher: Quality Press
Release Date : 2014-08-15
The Fda And Worldwide Current Good Manufacturing Practices And Quality System Requirements Guidebook For Finished Pharmaceuticals written by José Rodríguez-Pérez and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-15 with Business & Economics categories.
This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Quality Risk Management In The Fda Regulated Industry
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Author : Jose (Pepe) Rodriguez-Perez
language : en
Publisher: Quality Press
Release Date : 2024-04-18
Quality Risk Management In The Fda Regulated Industry written by Jose (Pepe) Rodriguez-Perez and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-04-18 with Business & Economics categories.
For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
Quality Risk Management In The Fda Regulated Industry
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Author : José Rodríguez-Pérez
language : en
Publisher: Quality Press
Release Date : 2017-02-21
Quality Risk Management In The Fda Regulated Industry written by José Rodríguez-Pérez and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-21 with Business & Economics categories.
The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
The Certified Pharmaceutical Gmp Professional Handbook
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-05-23
The Certified Pharmaceutical Gmp Professional Handbook written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-23 with Technology & Engineering categories.
The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Quality
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Author : Kathleen E. McCormick
language : en
Publisher: Butterworth-Heinemann
Release Date : 2022-07-14
Quality written by Kathleen E. McCormick and has been published by Butterworth-Heinemann this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-07-14 with Technology & Engineering categories.
Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. - Fully revised, updated, and expanded new edition - Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools - Includes end-of-chapter summaries and end-of-chapter question and/or problems - Provides detailed steps and examples for applying the guidelines and quality tools - Written in an accessible style making the content easy to understand and apply
The Asq Certified Pharmaceutical Gmp Professional Handbook
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2024-09-30
The Asq Certified Pharmaceutical Gmp Professional Handbook written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-09-30 with Technology & Engineering categories.
The ASQ Certified Pharmaceutical GMP Professional Handbook assists candidates preparing for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and serves as a handy reference guide for practitioners in the field. This handbook covers compliance with good manufacturing practices (GMPs) as regulated and guided by national and international agencies for the pharmaceutical industry.
Handbook Of Investigation And Effective Capa Systems
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Author : Jose (Pepe) Rodriguez-Perez
language : en
Publisher: Quality Press
Release Date : 2022-02-15
Handbook Of Investigation And Effective Capa Systems written by Jose (Pepe) Rodriguez-Perez and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-15 with Business & Economics categories.
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.
The Biomedical Quality Auditor Handbook Third Edition
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Author : Heather Crawford
language : en
Publisher: Quality Press
Release Date : 2017-09-08
The Biomedical Quality Auditor Handbook Third Edition written by Heather Crawford and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-08 with Business & Economics categories.
The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Practical Process Validation
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-07-11
Practical Process Validation written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-07-11 with Business & Economics categories.
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.
Human Error Reduction In Manufacturing
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Author : José Rodríguez-Pérez
language : en
Publisher: Quality Press
Release Date : 2018-08-27
Human Error Reduction In Manufacturing written by José Rodríguez-Pérez and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-27 with Technology & Engineering categories.
For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple industry language with abundant applied examples and practical references, this book's insights on human failure reduction will improve individual, organizational, and social well-being.