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A History of a cGMP Medical Event Investigation
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A History of a cGMP Medical Event Investigation (Paperback)

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Beginning with the untimely death of a young mother, this book 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. This case study introduces all the key regulations and practices that govern the development, manufacture, and marketing of a new drug. This book is ideal for professionals in biomedical and drug development.

Medical & VeterinaryBrances of medicinePharmacologyScience & MathematicsChemistryTechnicalIndustrial chemistry & manufacturing technologiesIndustrial chemistryChemical engineeringTechnicalIndustrial chemistry & manufacturing technologiesIndustrial chemistryPharmaceutical technology Publisher: John Wiley & Sons Inc Publication Date: 30/11/2012 ISBN-13: 9781118396612  Details: Type: Paperback Format: Books
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MICHAEL A. BROWN, PhD, PE, is a Visiting Professor at the University of Illinois at Chicago. Dr. Brown has twenty-five years' experience in the biomedical industry in a product and process design capacity with responsibilities for worldwide engineering and management. He has served as a lead engineer on numerous products, process, and equipment projects including design, implementation, and qualifications. He is a registered Professional Engineer and a certified Six Sigma Black Belt with considerable experience in team leadership. The material presented in this case, including the FDA regulations and Six Sigma concepts, was tested in an engineering senior design course taught by Dr. Brown over a three-year period. Student feedback noted that the difficult design principles were explained in an easy-to-read story that introduced them to the Six Sigma methodologies in an engaging manner.

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