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International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries
Siri H. Segalstad
€ 153.21
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Description for International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries
Hardcover. 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. Num Pages: 338 pages, Illustrations. BIC Classification: KND; LNQ. Category: (P) Professional & Vocational. Dimension: 254 x 175 x 24. Weight in Grams: 720.
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.
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.
Product Details
Format
Hardback
Publication date
2008
Publisher
John Wiley & Sons Inc United Kingdom
Number of pages
338
Condition
New
Number of Pages
338
Place of Publication
New York, United States
ISBN
9780470758823
SKU
V9780470758823
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50
About Siri H. Segalstad
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, ... Read more
Reviews for International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries
“This book is a good reference for everyone dealing with IT systems in a regulated environment. The style and content are targeted to entry- and middle-level professionals. The author provides readers with a broad picture and strong overall understanding of IT systems.” (Pharmaceutical Technology, June 2009)