A History of a CGMP Medical Event Investigation
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.