Mastering And Managing The Fda Maze
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Mastering And Managing The Fda Maze Second Edition
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Author : Gordon Harnack
language : en
Publisher: Quality Press
Release Date : 2014-04-14
Mastering And Managing The Fda Maze Second Edition written by Gordon Harnack and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-04-14 with Business & Economics categories.
The number of FDA regulations and the agencys increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firms employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
Mastering And Managing The Fda Maze
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Author : Gordon Harnack
language : en
Publisher: Quality Press
Release Date : 2014-07-18
Mastering And Managing The Fda Maze written by Gordon Harnack and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-18 with Business & Economics categories.
The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
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.
Commercializing Successful Biomedical Technologies
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Author : Shreefal S. Mehta
language : en
Publisher: Cambridge University Press
Release Date : 2022-10-31
Commercializing Successful Biomedical Technologies written by Shreefal S. Mehta and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-10-31 with Business & Economics categories.
Transform your ideas into commercial products through this updated second edition, with real-world case studies and industry tips.
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.
The Certified Pharmaceutical Gmp Professional Handbook Second Edition
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-05-26
The Certified Pharmaceutical Gmp Professional Handbook Second Edition 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 2016-05-26 with Business & Economics 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.
The Asq Certified Quality Improvement Associate Handbook
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Author : Grace L. Duffy
language : en
Publisher: Quality Press
Release Date : 2020-03-01
The Asq Certified Quality Improvement Associate Handbook written by Grace L. Duffy and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-01 with Technology & Engineering categories.
The ASQ Certified Quality Improvement Associate (CQIA) certification introduces the basics of quality to organizations and individuals who are new to quality. This book, and the Body of Knowledge (BoK) it supports, form a foundation for applying proven quality principles and practices that are used around the world. This handbook follows the CQIA span in both content and sequence. Let it serve as your guide in preparing for the ASQ CQIA examination, and refer to it frequently as you learn and implement these ideas and tools in your organization.
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.
The Certified Quality Improvement Associate Handbook Third Edition
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Author : Russell T. Westcott
language : en
Publisher: Quality Press
Release Date : 2014-10-01
The Certified Quality Improvement Associate Handbook Third Edition written by Russell T. Westcott and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-01 with Business & Economics categories.
ASQs Certified Quality Improvement Associate (CQIA) certification is designed to introduce the basics of quality to organizations and individuals not currently working within the field of quality. This book and the Body of Knowledge (BOK) it supports are intended to form a foundation for further study and application of proven quality principles and practices worldwide. The book follows the CQIA BoK in both content and sequence. The intent is that this book will serve as a guide to be used in preparation to take the CQIA examination given by ASQ. Each chapter stands alone, and the chapters may be read in any order. Some material reaching beyond the content of the BoK has been added. Supplemental reading suggestions are provided. An online, interactive sample exam and a paper-and-pencil sample can be found on the ASQ website (http://asq.org/cert/quality-improvement-associate/prepare).
Medical Device Design And Regulation
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Author : Carl T. DeMarco
language : en
Publisher: Quality Press
Release Date : 2011-01-01
Medical Device Design And Regulation written by Carl T. DeMarco and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-01 with Business & Economics categories.