Quality Assurance and Regulatory Affairs for the Biosciences

Quality Assurance and Regulatory Affairs for the Biosciences

Author: Jack O'Grady

Publisher:

Published: 2021-02-16

Total Pages: 207

ISBN-13:

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A solid and attractive book to learn. More than a compilation book of standards and techniques, this book provides a real and clear guide to learning about quality assurance and regulatory issues of pharmaceutical, biomedical and biotechnological products. In this short book, Jack O'Grady introduces dynamically and consistently the topics of greatest interest to the reader. Also, a series of links to the web pages of the relevant institutions (eg manuals, guides, statistics) is provided through scannable QR codes, thus granting a greater utility to the reader and reducing redundant and technical content to make reading more agile and productive. Table of Contents: Chapter 1. Introduction to Biotechnology and Quality Assurance. Chapter 2. Introduction to Quality Principles Chapter 3. Quality Management Systems Chapter 4. The Food and Drug Administration Chapter 5. Good Guidance Practices (GXPs) Chapter 6. The Drug Approval Process Chapter 7. The Regulation of Biologics Chapter 8. Medical Device and Combination Products Chapter 9. Regulation of Food and Other Products Chapter 10. FDA Enforcement ⚠ Before purchasing this book, consider: This book is not designed for experts in the field, as it may fall into the basics. This book is not a compendium of regulations but provides links to find them on the websites of the relevant institutions. This book does not compile analytical laboratory techniques. Instead, it explains the management of quality standards and management of product quality at the corporate level. This book is short and does not provide an exhaustive discussion of all the topics, however, it does provide a solid basis for the reader to delve into his interests.


Quality Assurance and Regulatory Affairs for the Biosciences

Quality Assurance and Regulatory Affairs for the Biosciences

Author: Jack O'Grady

Publisher:

Published: 2021-02-16

Total Pages: 207

ISBN-13:

DOWNLOAD EBOOK

A solid and attractive book to learn. More than a compilation book of standards and techniques, this book provides a real and clear guide to learning about quality assurance and regulatory issues of pharmaceutical, biomedical and biotechnological products. In this short book, Jack O'Grady introduces dynamically and consistently the topics of greatest interest to the reader. Also, a series of links to the web pages of the relevant institutions (eg manuals, guides, statistics) is provided through scannable QR codes, thus granting a greater utility to the reader and reducing redundant and technical content to make reading more agile and productive. Table of Contents: Chapter 1. Introduction to Biotechnology and Quality Assurance. Chapter 2. Introduction to Quality Principles Chapter 3. Quality Management Systems Chapter 4. The Food and Drug Administration Chapter 5. Good Guidance Practices (GXPs) Chapter 6. The Drug Approval Process Chapter 7. The Regulation of Biologics Chapter 8. Medical Device and Combination Products Chapter 9. Regulation of Food and Other Products Chapter 10. FDA Enforcement ⚠ Before purchasing this book, consider: This book is not designed for experts in the field, as it may fall into the basics. This book is not a compendium of regulations but provides links to find them on the websites of the relevant institutions. This book does not compile analytical laboratory techniques. Instead, it explains the management of quality standards and management of product quality at the corporate level. This book is short and does not provide an exhaustive discussion of all the topics, however, it does provide a solid basis for the reader to delve into his interests.


Drug Biotechnology Regulation

Drug Biotechnology Regulation

Author: Y. Chiu

Publisher: CRC Press

Published: 1991-01-07

Total Pages: 600

ISBN-13: 9780824784201

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An examination of the relation between biodrug development and governmental regulation, focusing on the present state of collective knowledge of biotechnological practitioners, including the identification of the scientific basis on regulatory requirements in the field, as well as ways in which the


Quality Assurance for Biopharmaceuticals

Quality Assurance for Biopharmaceuticals

Author: Jean F. Huxsoll

Publisher: Wiley-Interscience

Published: 1994-06-21

Total Pages: 222

ISBN-13:

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Dr. Jean Huxsoll and a team of distinguished biotechnology industry experts from the U.S. and Europe offer a wealth of practical guidelines to designing, implementing, and managing QA systems to assure that biopharmaceutical products meet standards for safety purity, and potency. Quality Assurance for Biopharmaceuticals covers all important theoretical and practical concerns, including detailed guidelines to meeting GMP compliance; quality assurance of production; quality assurance of analytical methods; advanced documentation, sampling, and validation techniques; comprehensive coverage of regulatory issues in the U.S., Europe, and Japan; and much more.


Research on the Management of Innovation

Research on the Management of Innovation

Author: Andrew H. Van de Ven

Publisher: Oxford University Press, USA

Published: 2000

Total Pages: 751

ISBN-13: 0195139763

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List of Figures. List of Tables. Preface to the Paperback Edition. Preface to the Original Edition. Section I: Overview of Research Program and Methods. 1. An Introduction to the Minnesota Innovation Research Program, Andrew H. Van de Ven and Harold L. Angle. 2. Methods for Studying Innovation Processes, Andrew H. Van de Ven and Marshall Scott Poole. 3. A Psychometric Assessment of the Minnesota Innovation Survey, Andrew H. Van de Ven and Yun-han Chu. Section II: The Minnesota Innovation Research Program Framework. 4. The Development of Innovation Ideas, Roger G. Schroeder, Andrew H. Van de Ve.


Expertise in Regulation and Law

Expertise in Regulation and Law

Author: Gary Edmond

Publisher: Routledge

Published: 2017-07-05

Total Pages: 340

ISBN-13: 1351937723

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This collection of essays examines the multi-faceted roles of experts and expertise in and around contemporary legal and regulatory cultures. The essays illustrate the complexity intrinsic to the production and use of expert knowledge, particularly during transition from specialist communities to other domains such as policy formulation, regulatory standard setting and litigation. Several themes pervade the collection. These include the need to recognize that: expert knowledge and opinion is often complex, controversial and contested; there are no simple criteria for resolving disagreements between experts; appeals to 'objectivity' and 'impartiality' tend to be rhetorical rather than analytical; contests in expertise are frequently episodes in larger campaigns; there are many different models of expertise and knowledge; processes designed to deal with expert knowledge are unavoidably political; questions around who is an expert and what should count as expertise are not always self-evident; and the evidence rarely 'speaks for itself'.


Safety Management

Safety Management

Author: Chitram Lutchman

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 488

ISBN-13: 1439862621

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With annual cost in excess of $150 billion from workplace related illnesses and injuries, any knowledge that can reduce this burden contributes to the overall welfare of the work force and business performance. Yet, there are many key areas of opportunities that have not yet been discussed in the literature, such as approaches to improving contract


Career Development in Bioengineering and Biotechnology

Career Development in Bioengineering and Biotechnology

Author: Guruprasad Madhavan

Publisher: Springer Science & Business Media

Published: 2009-01-07

Total Pages: 524

ISBN-13: 038776495X

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This indispensable guide provides a roadmap to the broad and varied career development opportunities in bioengineering, biotechnology, and related fields. Eminent practitioners lay out career paths related to academia, industry, government and regulatory affairs, healthcare, law, marketing, entrepreneurship, and more. Lifetimes of experience and wisdom are shared, including "war stories," strategies for success, and discussions of the authors’ personal views and motivations.