Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory [email protected] Rs [Mrp:-6995]

Product Image

Store : Amazon India Product Type : Book Brand : imusti Read Reviews
MRP : 6995 Rs Offer Price : 6225 Rs |Flat 11 % off| Click For More Offers

Important Features :

  • Informa Medical


Buy Online Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance at lowest price (6225 Rs) on Amazon India

Expert Review :

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Key topics in Pharmaceutical Computer Systems Validation, Second Edition include:

  • GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008
  • ICH Guidance Q8, Q9, and Q10 expectations
  • FDA cGMPs for the 21st Century Initiative and associated guidance
  • PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments
  • WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
  • the indirect developments from FDA/EU/Japan regulators and industry
  • the role of QA department, and internal and external suppliers
  • the integration of computer systems validation into single overall approach for wider system
  • practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system
  • managing outsource partners and handling legacy systems
  • topical issues uncovered by regulatory authorities including US FDA

Product Details :

Binding Hardcover
Brand imusti
Creator Guy Wingate
EAN 9781420088946
Edition 2
ISBN 1420088947
Label CRC Press
Manufacturer CRC Press
NumberOfItems 1
NumberOfPages 798
ProductGroup Book
ProductTypeName ABIS_BOOK
PublicationDate 2010-02-23
Publisher CRC Press
Studio CRC Press
Title Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance