Mastering and Managing the FDA Maze, Second Edition PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Mastering and Managing the FDA Maze, Second Edition PDF full book. Access full book title Mastering and Managing the FDA Maze, Second Edition by Gordon Harnack. Download full books in PDF and EPUB format.
Author: Gordon Harnack Publisher: Quality Press ISBN: 0873898877 Category : Business & Economics Languages : en Pages : 488
Book Description
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
Author: Gordon Harnack Publisher: Quality Press ISBN: 0873898877 Category : Business & Economics Languages : en Pages : 488
Book Description
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
Author: José Rodríguez-Pérez Publisher: Quality Press ISBN: 1953079326 Category : Business & Economics Languages : en Pages : 252
Book Description
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.
Author: Mark Allen Durivage Publisher: Quality Press ISBN: 0873899334 Category : Business & Economics Languages : en Pages : 386
Book Description
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.
Author: Heather Crawford Publisher: Quality Press ISBN: 0873899628 Category : Business & Economics Languages : en Pages : 271
Book Description
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.
Author: Mark Allen Durivage Publisher: Quality Press ISBN: 1636941028 Category : Business & Economics Languages : en Pages : 135
Book Description
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.
Author: Carl T. DeMarco Publisher: Quality Press ISBN: 0873891880 Category : Medical Languages : en Pages : 369
Book Description
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.
Author: Russell T. Westcott Publisher: Quality Press ISBN: 0873898907 Category : Business & Economics Languages : en Pages : 210
Book Description
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).
Author: Habib Samady Publisher: McGraw Hill Professional ISBN: 007182037X Category : Medical Languages : en Pages : 1313
Book Description
The first – and best – primer for the cardiovascular interventionalist – updated with more than twenty new chapters and all-new Q&A A Doody’s Core Title for 2021! 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.
Author: Grace L. Duffy Publisher: Quality Press ISBN: 1951058135 Category : Technology & Engineering Languages : en Pages : 362
Book Description
Intro / prep handbook on basics of the quality field / its philosophies for ASQE’s CQIA (Certified Quality Improvement Associate) certification exam.
Author: Gordon Harnack
Author: Gordon Harnack
Author: José Rodríguez-Pérez
Author: Mark Allen Durivage
Author: Heather Crawford
Author: Mark Allen Durivage
Author: Carl T. DeMarco
Author: Russell T. Westcott
Author: Habib Samady
Author: Shreefal S. Mehta
Author: Grace L. Duffy