Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance (Hardback)
  • Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance (Hardback)
zoom

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance (Hardback)

(editor)
£145.00
Hardback 798 Pages / Published: 23/02/2010
  • Not available

This product is currently unavailable.

  • This item has been added to your basket
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 2008ICH Guidance Q8, Q9, and Q10 expectationsFDA cGMPs for the 21st Century Initiative and associated guidancePIC/S Guidance on Good Practice for Computerized Systems in GxP EnvironmentsWK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipmentthe indirect developments from FDA/EU/Japan regulators and industrythe role of QA department, and internal and external suppliersthe integration of computer systems validation into single overall approach for wider systempractical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer systemmanaging outsource partners and handling legacy systemstopical issues uncovered by regulatory authorities including US FDA

Publisher: Taylor & Francis Inc
ISBN: 9781420088946
Number of pages: 798
Weight: 1520 g
Dimensions: 254 x 178 x 48 mm
Edition: 2nd New edition

You may also be interested in...

Great Medical Discoveries
Added to basket
ECG Pocket
Added to basket
£8.99
Paperback
The Cancer Chronicles
Added to basket
The Ct3m Handbook
Added to basket
£16.95
Paperback
Research Methods in Clinical Psychology
Added to basket
Stem Cells For Dummies
Added to basket
Dermoscopy
Added to basket
£59.99
Paperback
Oxford Handbook of Clinical Examination and Practical Skills
Added to basket
The Cancer Chronicles
Added to basket
Recovering with T3
Added to basket
£19.45
Paperback
Old Medical and Dental Instruments
Added to basket
The Immortal Life of Henrietta Lacks
Added to basket
How to Write a Grant Application
Added to basket
Evidence-Based Medicine
Added to basket
£34.99
Paperback

Reviews

Please sign in to write a review

Your review has been submitted successfully.