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Pharmaceutical Computer Systems Validation: Volume 2 - Real Life Case Studies (Drugs and the Pharmaceutical Sciences) - Tapa dura

 
9781041371151: Pharmaceutical Computer Systems Validation: Volume 2 - Real Life Case Studies (Drugs and the Pharmaceutical Sciences)
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ISBN 10: 1041371152 ISBN 13: 9781041371151
Editorial: CRC Press, 2026

Sinopsis

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. The 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 lifecycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and the opportunity 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 US FDA and other regulators
  • Discusses industry regulations and guidance, including current thinking of the US FDA on computer software assurance, the latest guidance from the US 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

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Acerca del autor

Guy Wingate, Ph.D., was Vice‑President of Compliance and before that Director of Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP® Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laroratoty Applications, Validating Corporate Computer Systems and previous editions of this book, Pharmaceutical Computer Systems Validation.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
CRC Press
Año de publicación
2026
Idioma
Inglés
ISBN 10 
1041371152
ISBN 13 
9781041371151
Encuadernación
Tapa dura
Número de edición
3
Número de páginas
488
Editor
Wingate Guy
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania