Computer systems validation quality (10 Ergebnisse)
- Softcover
- Internationale Ausgabe
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Zustand: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed… on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.
- Softcover
- Internationale Ausgabe
Anbieter: Romtrade Corp., STERLING HEIGHTS, MI, USARomtrade Corp.
Verkäufer/-in kontaktierenVerkäufer/-in mit 5 SternenInternationale AusgabeZustand: Neu
EUR 67,51
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Zustand: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed… on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.
- Softcover
Anbieter: Revaluation Books, Exeter, Vereinigtes KönigreichRevaluation Books
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EUR 105,82
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Paperback. Zustand: Brand New. 2nd edition. 798 pages. 10.00x7.00x10.00 inches. In Stock.
- Softcover
Anbieter: preigu, Osnabrück, Deutschlandpreigu
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EUR 54,85
EUR 70,00 VersandVersand von Deutschland nach USAAnzahl: 5 verfügbar
Taschenbuch. Zustand: Neu. Pharmaceutical Computer Systems Validation | Quality Assurance, Risk Management and Regulatory Compliance | Guy Wingate | Taschenbuch | Einband - flex.(Paperback) | Englisch | 2024 | CRC Press | EAN 9781032917511 | Verantwortliche Person für die EU: Taylor & Francis Verlag GmbH, Kaufingerstr. 24, 80331… München, gpsr[at]taylorandfrancis[dot]com | Anbieter: preigu.
- Hardcover
Anbieter: Revaluation Books, Exeter, Vereinigtes KönigreichRevaluation Books
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EUR 244,12
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Hardcover. Zustand: Brand New. 1st edition. 325 pages. 10.25x7.25x1.00 inches. In Stock.
- Hardcover
Anbieter: Majestic Books, Hounslow, Vereinigtes KönigreichMajestic Books
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EUR 274,08
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Zustand: New.
- Hardcover
Anbieter: Revaluation Books, Exeter, Vereinigtes KönigreichRevaluation Books
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EUR 390,50
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Hardcover. Zustand: Brand New. 3rd edition. 440 pages. 10.00x7.00x10.00 inches. In Stock.
- Hardcover
Anbieter: Revaluation Books, Exeter, Vereinigtes KönigreichRevaluation Books
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EUR 396,11
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Hardcover. Zustand: Brand New. 2nd edition. 832 pages. 10.00x7.00x1.75 inches. In Stock.
- Hardcover
Anbieter: AHA-BUCH GmbH, Einbeck, DeutschlandAHA-BUCH GmbH
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EUR 404,00
EUR 65,64 VersandVersand von Deutschland nach USAAnzahl: 2 verfügbar
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.
- Hardcover
Anbieter: AHA-BUCH GmbH, Einbeck, DeutschlandAHA-BUCH GmbH
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EUR 504,72
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Buch. Zustand: Neu. Neuware - The most comprehensive guide to computer validation currently available, this invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US, European and other regulatory authorities. Practical examples…and checklists appear throughout the book and the authors explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. He reviews over twenty case studies of different types of computer systems. Latest FDA and PIC/S developments concerning computer validation, electronic records and signatures, and process analytical technologies are included.
