The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel

Publisher: ASQ Quality Press

ISBN: 0873897404

Category: Medical

Page: 304

View: 9403

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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: N.A

Publisher: Asq Press

ISBN: N.A

Category: Law

Page: 210

View: 1307

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This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DIS 13485:1996). Icons quickly establish the differences and relationship between FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization Task Force (GHTF) guidance. In addition, the end of each subsection includes blank pages for your notes. This book allows manufacturers to establish a single quality system that satisfies world requirements.

The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Author: José Rodríguez-Pérez

Publisher: ASQ Quality Press

ISBN: 0873898699

Category: Business & Economics

Page: 396

View: 7248

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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.

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Author: Mark Allen Durivage

Publisher: ASQ Quality Press

ISBN: 0873899334

Category: Business & Economics

Page: 516

View: 7979

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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.

Medical Device Regulatory Practices

An International Perspective

Author: Val Theisz

Publisher: CRC Press

ISBN: 9814669113

Category: Medical

Page: 590

View: 3596

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This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

Handbook of Investigation and Effective CAPA Systems, Second Edition

Author: José Rodríguez-Pérez

Publisher: ASQ Quality Press

ISBN: 0873899261

Category: Business & Economics

Page: 234

View: 3147

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Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: Information about the importance of the CAPA system within the quality system for the medical products regulated industry. Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. An example of an investigation and CAPA expert certification program being used for many companies. Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format. While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.

ISO 13485 Starter Guide

Author: Emmet Tobin

Publisher: Createspace Independent Publishing Platform

ISBN: 9781534675278

Category:

Page: 86

View: 3908

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This short concise book provides an introduction to ISO 13485. It introduces the core themes of the standard to those who wish to work in regulated industries such as medical devices, highlighting key areas and practices. It is a perfect introduction for operators, factory workers, engineers and managers wishing to learn the fundamentals. It is also a useful pocket reference book, small enough to slip into a case or pocket. ISO 13485 is the Quality management standard of choice for manufactures of medical devices. Revised in 2016, ISO 13485:2016 "specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements."1 The scope of the standard can apply to any organization or company involved in throughout the life-cycle of a product, including design and/or development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of technical or professional services. (Page count 86 pages)

The Lean Six Sigma Black Belt Handbook

Tools and Methods for Process Acceleration

Author: Frank Voehl,H. James Harrington,Chuck Mignosa,Rich Charron

Publisher: CRC Press

ISBN: 146655469X

Category: Business & Economics

Page: 621

View: 3132

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Although Lean and Six Sigma appear to be quite different, when used together they have shown to deliver unprecedented improvements to quality and profitability. The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Acceleration explains how to integrate these seemingly dissimilar approaches to increase production speed while decreasing variations and costs in your organization. Presenting problem-solving tools you can use to immediately determine the sources of the problems in your organization, the book is based on a recent survey that analyzed Six Sigma tools to determine which are the most beneficial. Although it focuses on the most commonly used tools, it also includes coverage of those used a minimum of two times on every five Six Sigma projects. Filled with diagrams of the tools you’ll need, the book supplies a comprehensive framework to help you for organize and process the vast amount of information currently available about Lean, quality management, and continuous improvement process applications. It begins with an overview of Six Sigma, followed by little-known tips for using Lean Six Sigma (LSS) effectively. It examines the LSS quality system, its supporting organization, and the different roles involved. Identifying the theories required to support a contemporary Lean system, the book describes the new skills and technologies that you need to master to be certified at the Lean Six Sigma Black Belt (LSSBB) level. It also covers the advanced non-statistical and statistical tools that are new to the LSSBB body of knowledge. Presenting time-tested insights of a distinguished group of authors, the book provides the understanding required to select the solutions that best fit your organization's aim and culture. It also includes exercises, worksheets, and templates you can easily customize to create your own handbook for continuous process improvement. Designed to make the methodologies you choose easy to follow, the book will help Black Belts and Senseis better engage their employees, as well as provide an integrated and visual process management structure for reporting and sustaining continuous improvement breakthroughs and initiatives.

Cannabis Pharmacy

The Practical Guide to Medical Marijuana -- Revised and Updated

Author: Michael Backes

Publisher: Black Dog & Leventhal

ISBN: 031655572X

Category: Health & Fitness

Page: 320

View: 3738

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In Cannabis Pharmacy, expert Michael Backes offers evidence-based information on using cannabis to treat an array of ailments and conditions. He provides information on how cannabis works with the body's own system, how best to prepare and administer it, and how to modify and control dosage. This newly revised edition is now completely up-to-date with the latest information on the body's encannabinoid system, which is now understood to control emotion, appetite, and memory, delivery and dosing of cannabis, including e-cigarette designs, additional varietals, and a new system for classification, as well as 21 additional ailments and conditions that can be treated with medical marijuana. There are currently more than 4.2 million medical cannabis patients in the United States, and there are 29 states plus the District of Columbia where medical cannabis is legal.

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Author: Mark Allen Durivage

Publisher: ASQ Quality Press

ISBN: 0873899334

Category: Business & Economics

Page: 516

View: 1388

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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.

The Certified Quality Technician Handbook, Second Edition

Author: H. Fred Walker,Donald W. Benbow,Ahmad K. Elshennawy

Publisher: ASQ Quality Press

ISBN: 0873898354

Category: Technology & Engineering

Page: 256

View: 9254

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The quality technician is a person responsible for understanding and utilizing quality concepts and tools, statistical techniques, metrology and calibration procedures and protocols, inspection and test techniques, quality auditing, and preventive and corrective action in the context of product/process/service improvement or in correcting problems. Quality technicians frequently work in the quality function of organizations in the various measurement and inspection laboratories, as well as on the shop floor supporting and interacting with quality engineers, mechanical inspectors, and production/service delivery personnel. This book supports individuals preparing for, or those already performing, this type of work. It is intended to serve as a ready reference for quality technicians and quality technicians-in-training, as well as a comprehensive reference for those individuals preparing to take the ASQ Certified Quality Technician (CQT) examination. Examples and problems used throughout the handbook are thoroughly explained, are algebra-based, and are drawn from “real world” situations encountered in the quality profession. To assist readers in using the book as a ready reference or as a study aid, the book has been organized so as to conform closely to the CQT Body of Knowledge (BoK).

The Certified HACCP Auditor Handbook, Third Edition

Author: ASQ's Food, Drug, and Cosmetic Division

Publisher: ASQ Quality Press

ISBN: 0873898680

Category: Business & Economics

Page: 312

View: 7710

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This handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) knowledge for quality auditors. HACCP is more than just failure mode and effect analysis (FMEA) for food: it is a product safety management system that evolved and matured in the commercial food processing industry allowing food processors to take a proactive approach to prevent foodborne diseases. Both the FDA and the USDA have embraced HACCP as the most effective method to ensure farm-to-table food safety in the United States. This handbook also assists the certification candidate preparing for the ASQ Certified HACCP Auditor (CHA) examination. It includes chapters covering the HACCP audit, the HACCP auditor, and quality assurance analytical tools.

Statistical Process Control for the FDA-Regulated Industry

Author: Manuel E. Pena-Rodriguez

Publisher: ASQ Quality Press

ISBN: 0873898524

Category: Business & Economics

Page: 204

View: 5931

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The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author’s almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.

The Medical Device Engineers Handbook

Author: Emmet Tobin

Publisher: N.A

ISBN: 9781534783195

Category:

Page: 262

View: 1017

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This book aims to create a new standard resource for engineers working in the medical device industry. The objective was to produce an all-in-one reference-style book serving the needs of engineers at different levels in their career journey. It is based on over a decade of experience working within the industry. It draws not only on this experience but on best practices and widely accepted conventions. These practices and conventions are typically shaped by the demands of regulatory bodies and international organisations. Chapters include: Design Controls Validation Planning Risk Management Facilities and Utilities Validation Equipment and Software Validation Process Validation Packaging Validation Test Method Validation 21 CFR Part 11 Electronic Records Measurement Good Manufacturing Practices ISO 13485 Lean Basics Six Sigma Basics Polymer Processing Tools Useful References Page Count (Over 200 pages)

Human Error Reduction in Manufacturing

Author: José Rodríguez-Pérez

Publisher: ASQ Quality Press

ISBN: 0873899733

Category: Business & Economics

Page: 268

View: 5143

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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.