The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author:
Publisher: Asq Press
ISBN:
Format: PDF, Mobi
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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 Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel
Publisher: ASQ Quality Press
ISBN: 0873897404
Format: PDF
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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.

Handbook of Investigation and Effective CAPA Systems Second Edition

Author: José Rodríguez-Pérez
Publisher: ASQ Quality Press
ISBN: 0873899261
Format: PDF, Mobi
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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.

Medical Device Regulatory Practices

Author: Val Theisz
Publisher: CRC Press
ISBN: 9814669113
Format: PDF, ePub
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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.

Mastering and Managing the FDA Maze

Author: Gordon Harnack
Publisher: ASQ Quality Press
ISBN: 9780873894555
Format: PDF
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There is a mountain of information on FDA regulation and compliance for medical device manufacturers. the task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is key. Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with a FDA Investigator Icon, which summarizes what the FDA investigator will expect to see during an investigation.

The Certified Pharmaceutical GMP Professional Handbook Second Edition

Author: Mark Allen Durivage
Publisher: ASQ Quality Press
ISBN: 0873899334
Format: PDF, Docs
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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.

Cannabis Pharmacy

Author: Michael Backes
Publisher: Black Dog & Leventhal
ISBN: 031655572X
Format: PDF
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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 Lean Six Sigma Black Belt Handbook

Author: Frank Voehl
Publisher: CRC Press
ISBN: 146655469X
Format: PDF, ePub, Mobi
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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.