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(Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition by John Andrews ISBN 9780203500439 B00SC8L32Q

  • SKU: EBN-12052342
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Authors:John Andrews (Editor)
Pages:0 pages.
Year:2005
Editon:1
Publisher:CRC Press
Language:english
File Size:3.23 MB
Format:pdf
ISBNS:9780203500439, 9780367392383, 9780429210358, 9780849323249, 9781135487942, 9781135487966, 9781135487980, 9781135487997
Categories: Ebooks

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(Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition by John Andrews ISBN 9780203500439 B00SC8L32Q

(Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition by John Andrews - Ebook PDF Instant Download/Delivery: 9780203500439 ,B00SC8L32Q
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Product details:

ISBN 10: B00SC8L32Q
ISBN 13: 9780203500439
Author: John Andrews

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners
 

(Ebook) Validating Pharmaceutical Systems Good Computer Practice in Life Science Manufacturing 1st Edition Table of contents:

Chapter 1 Considerations for Computerized System Validation in the 21st Centu ry Life Sciences Sector

Chapter 2 An Inspector’s Viewpoint

Chapter 3 State-of-the-Art Risk Assessment and Management

Chapter 4 Validation Planning and Reporting

Chapter 5 Supplier Audits: Questions and Answers

Chapter 6 Developing Good Specifications

Chapter 7 Traceability of Requirements Throughout the Life Cycle

Chapter 8 Good Documentation in Practice

Chapter 9 Good Testing Practice: Part 1

Chapter 10 Enterprise Resource Planning Systems — Aligning Business andVali dation Requirements

Chapter 11 Calibration in Practice

Chapter 12 Validating Legacy Systems

Chapter 13 Technology Transfer Keys

Chapter 14 Qualifying SCADA Systems in Practice Acquisition*

Chapter 15 The Application of GAMP 4 Guidelines to Computer Systems Found inGL P-Regulated Areas

Chapter 16 The Validation of a LIMS System

Chapter 17 Compliance and Validation in Central and Eastern Europe(CEE)

Chapter 18 Distribution Management Validation in Practice

Chapter 19 Good Testing Practice: Part 2

Chapter 20 Practical Applications of GAMP Version 4

Chapter 21 Glossary and Abbreviations

Index

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Tags: John Andrews, Validating Pharmaceutical Systems, Computer Practice, Life Science Manufacturing

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