International IT Regulations and Compliance – Quality Standards in the Pharmaceutical and Regulated Industries

en Limba Engleză Hardback – 23 oct 2008

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.

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Specificații

ISBN-13: 9780470758823
ISBN-10: 0470758821
Pagini: 338
Dimensiuni: 172 x 252 x 24 mm
Greutate: 0.72 kg
Editura: Wiley
Locul publicării:Chichester, United Kingdom

Public țintă

Pharmaceutical and semiconductor industries; other regulated industries and ISO certified industry / accredited laboratories

Descriere scurtă

Cuprins

Notă biografică

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.

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