Pre-Production Quality Assurance for Healthcare Manufacturers

G. William Hough, David A. Rawlings and Michael F.

Detalles del libro
Editorial: CRC Press
ISBN: 1-57491-045-0
ISBN-13: 9781574910452
Materia: Libros de Farmacologia
The FDA and ISO 9001 require manufacturers to institute comprehensive and rigorous pre-production quality assurance processes to assure that design defects will be eliminated prior to manufacture and product sale. Pre-Production Quality Assurance for Healthcare Manufacturers addresses the product design and development phases for a medical product life cycle and shows how this effort can be successfully undertaken in accord with current Good Practice and ISO 9001. The authors provide a detailed step-by-step approach to ensuring that effective pre-production quality assurance is established and effectively in place and explore the key concepts of design, product, and process.