(Išleidimo metai: 16-Apr-2010, Hardback, Leidėjas: John Wiley & Sons Inc, ISBN-13: 9780470467084)
The authors provide advice regarding compliance with the drug development documentation and records management requirements of the US Food & Drug Administration. They address the relevant regulations, people and processes in documentation, principles...Daugiau...
(Išleidimo metai: 18-Mar-2010, Other digital carrier, Leidėjas: Wiley-Blackwell, ISBN-13: 9780470597507)
This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or...Daugiau...