International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries - Couverture rigide

Segalstad, Siri H.

Couverture rigide

ISBN 10 : 0470758821 ISBN 13 : 9780470758823

Editeur : John Wiley & Sons Inc, 2008

Synopsis

Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.

A propos du livre

À propos de l'auteur

Siri Segalstad has worked with quality and validation of IT systems since 1988 in and with the pharmaceutical industry. She set-up her own consulting company, Segalstad Consulting AS, covering these issues in 1995, and has hands-on experience with major companies in the US and in 10 countries in Europe, including Alpharma, AstraZeneca, Bayer, GE Health, Lundbeck, Nycomed, Pharmacia & Upjohn, Statoil, and various accredited laboratories. She has published more than 20 papers and given presentations and taught classes on validation from Hong Kong, Singapore, Taiwan, and Dubai in the East to California in the West.
She has been on the board of the GAMP (Good Automated Manufacturing Practice) Nordic Steering Committee since its inauguration in 2001, and has participated in preparing standards in ASTM and GAMP.

Détails de l'édition

• Éditeur: John Wiley & Sons Inc
• Date d'édition: 2008
• Langue: anglais
• ISBN 10: 0470758821
• ISBN 13: 9780470758823
• Reliure: Relié
• Nombre de pages: 344
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible