A History of a cGMP Medical Event Investigation

Nonfiction, Science & Nature, Technology, Industrial Health & Safety
Cover of the book A History of a cGMP Medical Event Investigation by Michael A. Brown, Wiley
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Michael A. Brown ISBN: 9781118494882
Publisher: Wiley Publication: November 27, 2012
Imprint: Wiley Language: English
Author: Michael A. Brown
ISBN: 9781118494882
Publisher: Wiley
Publication: November 27, 2012
Imprint: Wiley
Language: English

Case study details the right way and the wrong way to successfully develop and market a new drug

Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization.

From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including:

  • FDA Investigational and New Drug Application Processes
  • FDA Code of Federal Regulations' current Good Manufacturing Practice (cGMP)
  • ISPE Good Automated Manufacturing Practice (GAMP)

Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments.

A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

Case study details the right way and the wrong way to successfully develop and market a new drug

Beginning with the untimely death of a young mother, A History of a cGMP Medical Event Investigation unfolds a fictitious case study that captures how unchecked human flaws during the development and launch of a new drug can lead to disastrous consequences. Moreover, it illustrates how and why Six Sigma principles and methods should be applied to fully comply with FDA regulations at every stage of drug development and commercialization.

From initial transgenic mouse studies to the FDA fatality investigation, this case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug, including:

Readers will also be introduced to a variety of managers and researchers whose personal agendas conflict with best practices and therefore compromise the safety and effectiveness of a new drug product. Throughout the case study, the author offers tested and proven practices and tips so that these human flaws are not translated into drug product flaws. These practices and tips are critical and typically can only be learned through years of experience working in competitive drug development environments.

A History of a cGMP Medical Event Investigation is ideal for students in biotechnology, pharmacology, engineering, and business management as well as professionals in biomedical and drug development. All readers will discover what can go wrong in developing and bringing a new drug to market. Most importantly, they will also learn how to apply Six Sigma principles and methods to ensure safe and effective product design, development, and manufacturing.

More books from Wiley

Cover of the book Queer Visibilities by Michael A. Brown
Cover of the book Humanise by Michael A. Brown
Cover of the book The Shipping Point by Michael A. Brown
Cover of the book All Time Essentials for Entrepreneurs by Michael A. Brown
Cover of the book Electronic Health Record by Michael A. Brown
Cover of the book Suggestibility in Legal Contexts by Michael A. Brown
Cover of the book Adams and Stashak's Lameness in Horses by Michael A. Brown
Cover of the book Integration of Large Scale Wind Energy with Electrical Power Systems in China by Michael A. Brown
Cover of the book The Wiley-Blackwell Encyclopedia of Eighteenth-Century Writers and Writing 1660 - 1789 by Michael A. Brown
Cover of the book Hydrogen Storage Technologies by Michael A. Brown
Cover of the book Therapeutic Landscapes by Michael A. Brown
Cover of the book Organic Structures from 2D NMR Spectra by Michael A. Brown
Cover of the book Wellbeing: A Complete Reference Guide, Economics of Wellbeing by Michael A. Brown
Cover of the book Materials and Infrastructures 2 by Michael A. Brown
Cover of the book Introductory Phonology by Michael A. Brown
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy