Mastering and Managing the FDA Maze, Second Edition

Mastering and Managing the FDA Maze, Second Edition

Author: Gordon Harnack

Publisher: Quality Press

Published: 2014-04-14

Total Pages: 484

ISBN-13: 0873898877

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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


Book Synopsis Mastering and Managing the FDA Maze, Second Edition by : Gordon Harnack

Download or read book Mastering and Managing the FDA Maze, Second Edition written by Gordon Harnack and published by Quality Press. This book was released on 2014-04-14 with total page 484 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Mastering and Managing the FDA Maze

Mastering and Managing the FDA Maze

Author: Gordon Harnack

Publisher: Quality Press

Published: 2014-07-18

Total Pages: 501

ISBN-13: 1636940463

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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


Book Synopsis Mastering and Managing the FDA Maze by : Gordon Harnack

Download or read book Mastering and Managing the FDA Maze written by Gordon Harnack and published by Quality Press. This book was released on 2014-07-18 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Quality Risk Management in the FDA-Regulated Industry

Author: José Rodríguez-Pérez

Publisher: Quality Press

Published: 2017-02-21

Total Pages: 252

ISBN-13: 1953079326

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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.


Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, Second Edition

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Author: Mark Allen Durivage

Publisher: Quality Press

Published: 2016-05-26

Total Pages: 516

ISBN-13: 0873899334

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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.


Book Synopsis The Certified Pharmaceutical GMP Professional Handbook, Second Edition by : Mark Allen Durivage

Download or read book The Certified Pharmaceutical GMP Professional Handbook, Second Edition written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-26 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Biomedical Quality Auditor Handbook, Third Edition

The Biomedical Quality Auditor Handbook, Third Edition

Author: Heather Crawford

Publisher: Quality Press

Published: 2017-09-08

Total Pages: 300

ISBN-13: 0873899628

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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 ASQ’s 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.


Book Synopsis The Biomedical Quality Auditor Handbook, Third Edition by : Heather Crawford

Download or read book The Biomedical Quality Auditor Handbook, Third Edition written by Heather Crawford and published by Quality Press. This book was released on 2017-09-08 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 ASQ’s 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

Practical Process Validation

Author: Mark Allen Durivage

Publisher: Quality Press

Published: 2016-07-11

Total Pages: 135

ISBN-13: 1636941028

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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.


Book Synopsis Practical Process Validation by : Mark Allen Durivage

Download or read book Practical Process Validation written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-07-11 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Device Design and Regulation

Medical Device Design and Regulation

Author: Carl T. DeMarco

Publisher: Quality Press

Published: 2011-01-24

Total Pages: 369

ISBN-13: 0873891880

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The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.


Book Synopsis Medical Device Design and Regulation by : Carl T. DeMarco

Download or read book Medical Device Design and Regulation written by Carl T. DeMarco and published by Quality Press. This book was released on 2011-01-24 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

The Certified Quality Improvement Associate Handbook, Third Edition

The Certified Quality Improvement Associate Handbook, Third Edition

Author: Russell T. Westcott

Publisher: Quality Press

Published: 2014-10-01

Total Pages: 210

ISBN-13: 0873898907

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ASQ’s 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).


Book Synopsis The Certified Quality Improvement Associate Handbook, Third Edition by : Russell T. Westcott

Download or read book The Certified Quality Improvement Associate Handbook, Third Edition written by Russell T. Westcott and published by Quality Press. This book was released on 2014-10-01 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: ASQ’s 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).

Interventional Cardiology, Second Edition

Interventional Cardiology, Second Edition

Author: Habib Samady

Publisher: McGraw Hill Professional

Published: 2018-01-12

Total Pages: 960

ISBN-13: 007182037X

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The first – and best – primer for the cardiovascular interventionalist – updated with more than twenty new chapters and all-new Q&A Filling a crucial gap in procedural knowledge, this groundbreaking reference was the first to focus on interventional cardiovascular procedures. Interventional Cardiology, Second Edition includes a completely updated section on procedures, as well as chapters on the necessary scientific foundation, to which specialists will refer every day in their clinical practice. In addition, each procedural chapter is enhanced by valuable tips and pitfalls from an internationally recognized group of experts. The comprehensive coverage of this groundbreaking resource is highly accessible, thanks to a well-organized full-color format that synthesizes important information and provides a consistent template in describing each procedure. Throughout the book, charts and tables help to summarize key concepts and can serve as the basis for a detailed overview. FEATURES: •NEW to this edition: Multiple-choice questions (with answers) at the end of most chapters •21 NEW CHAPTERS, including History of Interventional Cardiology, Publishing Interventional Cardiology Research, Web-Based Learning, Medical Simulation in Interventional Cardiology, Emerging Clinical Applications of Physiologic and Intravascular Imaging Tools, An Overview of MitraClip Procedure, Cell Therapy for Cardiovascular Disease, and more •Edited by some of the foremost experts in the field, and featuring contributions from key opinion leaders in interventional cardiology •Top-to-bottom coverage of the latest interventional cardiology techniques •Valuable perspectives on avoiding and properly managing complications •Up-to-date information on devices •Numerous high-quality full-color images and figures throughout •High-yield content makes it valuable for board review •More than 1,500 illustrations, including more than 600 full-color photographs.


Book Synopsis Interventional Cardiology, Second Edition by : Habib Samady

Download or read book Interventional Cardiology, Second Edition written by Habib Samady and published by McGraw Hill Professional. This book was released on 2018-01-12 with total page 960 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first – and best – primer for the cardiovascular interventionalist – updated with more than twenty new chapters and all-new Q&A Filling a crucial gap in procedural knowledge, this groundbreaking reference was the first to focus on interventional cardiovascular procedures. Interventional Cardiology, Second Edition includes a completely updated section on procedures, as well as chapters on the necessary scientific foundation, to which specialists will refer every day in their clinical practice. In addition, each procedural chapter is enhanced by valuable tips and pitfalls from an internationally recognized group of experts. The comprehensive coverage of this groundbreaking resource is highly accessible, thanks to a well-organized full-color format that synthesizes important information and provides a consistent template in describing each procedure. Throughout the book, charts and tables help to summarize key concepts and can serve as the basis for a detailed overview. FEATURES: •NEW to this edition: Multiple-choice questions (with answers) at the end of most chapters •21 NEW CHAPTERS, including History of Interventional Cardiology, Publishing Interventional Cardiology Research, Web-Based Learning, Medical Simulation in Interventional Cardiology, Emerging Clinical Applications of Physiologic and Intravascular Imaging Tools, An Overview of MitraClip Procedure, Cell Therapy for Cardiovascular Disease, and more •Edited by some of the foremost experts in the field, and featuring contributions from key opinion leaders in interventional cardiology •Top-to-bottom coverage of the latest interventional cardiology techniques •Valuable perspectives on avoiding and properly managing complications •Up-to-date information on devices •Numerous high-quality full-color images and figures throughout •High-yield content makes it valuable for board review •More than 1,500 illustrations, including more than 600 full-color photographs.

Commercializing Successful Biomedical Technologies

Commercializing Successful Biomedical Technologies

Author: Shreefal S. Mehta

Publisher: Cambridge University Press

Published: 2022-10-31

Total Pages: 457

ISBN-13: 1316510069

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Transform your ideas into commercial products through this updated second edition, with real-world case studies and industry tips.


Book Synopsis Commercializing Successful Biomedical Technologies by : Shreefal S. Mehta

Download or read book Commercializing Successful Biomedical Technologies written by Shreefal S. Mehta and published by Cambridge University Press. This book was released on 2022-10-31 with total page 457 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transform your ideas into commercial products through this updated second edition, with real-world case studies and industry tips.