9781032981086 - pharmaceutical computer systems validation: volume 1 - quality assurance, risk management and regulatory compliance (drugs and the pharmaceutical sciences, band 1) (6 Ergebnisse)
- Hardcover
Anbieter: Majestic Books, Hounslow, Vereinigtes KönigreichMajestic Books
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EUR 273,47
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Zustand: New.
- Hardcover
Anbieter: PBShop.store UK, Fairford, GLOS, Vereinigtes KönigreichPBShop.store UK
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HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
- Hardcover
Anbieter: PBShop.store US, Wood Dale, IL, USAPBShop.store US
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EUR 314,81
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HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.
- Softcover
Anbieter: moluna, Greven, Deutschlandmoluna
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EUR 290,44
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Zustand: New. Guy Wingate, PhD, was Vice President & Compliance Officer and before that Director Global Computer Validation at GlaxoSmithKline until his recent retirement. A well-known speaker on computer validation, he has over 30 years of experi.
- Hardcover
Anbieter: Revaluation Books, Exeter, Vereinigtes KönigreichRevaluation Books
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EUR 388,26
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Hardcover. Zustand: Brand New. 3rd edition. 440 pages. 10.00x7.00x10.00 inches. In Stock.
- Hardcover
Anbieter: AHA-BUCH GmbH, Einbeck, DeutschlandAHA-BUCH GmbH
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EUR 404,00
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Buch. Zustand: Neu. Neuware - Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. T…he first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.Key Features - Covers governance framework, roles and responsibilities, quality culture, project life cycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and opportunities for performance improvement. - Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice. - Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs-complete with observations from inspections by the U.S. FDA and other regulators. - Discusses industry regulations and guidance, including current thinking of the U.S. FDA on computer software assurance, the latest guidance from the U.S. FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition). - Shares the practical experience and advice from a group of leading computer validation and compliance international experts.
