Автор: Carmen Medina
Название: Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics
Издательство: CRC Press
Год: 2003
ISBN: 978-0824740788
Серия: Drugs and the Pharmaceutical Sciences (Book 136)
Язык: English
Формат: pdf
Размер: 15,8 mb
Страниц: 704

The art of compliance is a craft much like that of a carpenter who learns to work with various kinds of wood and designs. Ours is an industry wrought with differences. While the regulations that govern FDA-regulated industries are proscribed, how the regulations are interpreted and applied really depends on experience and how well one has mastered the craft of compliance. There are no proscribed procedures, but there are guideposts common to all FDA-regulated industries, whether a firm manufactures medical devices, pharmaceuticals, or biological products.

This book is about how to hone the craft of compliance, and how to take basic guideposts and apply them to your specific company culture and needs. This book is not about how to adopt completely new methods and systems, but rather how to adapt proven ideas and strategies to your current practices.