Must-reading for anyone involved in the regulatory, quality assurance, and documentation processes, this practical book will help you establish a sound and documented quality system in the device and diagnostic industry. Dr. Steven Kuwahara explains and clearly illustrates step-by-step documentation and implementation methods for every section of the U.S. Quality Systems Regulations (21 CFR 820), and the Device Current Good Manufacturing Practices (CGMP). Tips on evaluating your own organization's existing documentation, and whether it meets worldwide quality systems requirements are also featured. Comparative clauses between ISO 9001 and 21 CFR 820 are illustrated in a useful table. A helpful glossary that identifies often-used abbreviations and acronyms is also included. 

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