The FDA establishes the manufacturer's responsibility for medical device packaging, but provides no direction on how to achieve compliance. Highlighting the recent development in industry regulations, this book demystifies the validation procedure. The author presents real-life examples and case studies, templates for creating and maintaining a validation file, and explains how the process and regulation works. He addresses the specific needs for validation of packaging for medical devices and covers laws, regulations, guidelines, and process capability studies. The book shows readers how to develop and implement a simple validation process for package design and processing.
