A History of a cGMP Medical Event Investigation (PDF)

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.