"This book is an essential reference on the desk of executive management, middle management, and operations (e.g., production, validation, quality control, regulatory, quality assurance, labeling and packaging, metrology, engineering, maintenance) in support of understanding technical and compliance requirements. Not only does it provide regulatory requirement interpretation and important information for new hires but also for personnel changing career paths within the industry. Even the experienced operational and quality professional will gain additional knowledge. The chapters provide companies within and outside the USA with indispensable information which is value added considering the cost of developing new products and the immeasurable cost of non-compliance resulting in regulatory actions preventing/restricting product marketing."--Page 4 de la couverture.