William Gibson, Keith Powell-Evans

Validation Fundamentals

How to, What to, When to Validate

• Gebundenes Buch

Produktbeschreibung

Written by the founders of the Institute of Validation, this introduction to validation cuts through all the jargon and focuses on the essentials. Valuable to novices and experienced validators alike, this book helps readers understand validation fundamentals and how these principles can help build the highest quality into products. The authors address associated costs, responsibilities, policies, strategies, support activities, SOPs, Master Plans, and other related subjects. The book also provides tools that support understanding the logic behind the validation process and covers testing, certification, protocols, final reports, sign-offs, and ways to create seamless audit trails.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 248
• Erscheinungstermin: 30. April 1998
• Englisch
• Abmessung: 235mm x 157mm x 18mm
• Gewicht: 515g
• ISBN-13: 9781574910704
• ISBN-10: 1574910701
• Artikelnr.: 23308855

Autorenporträt

William Gibson

Inhaltsangabe

What Is Validation?. History & Roots of Validation. Why Do We Validate &
How Much Does It Cost? Who Is Responsible for Validation? How Does
Validation Affect You? Validation Policy, Strategy Protocols, & the
Validation Report. What Activities Support the Validation Effort? What Are
the Consequences of Not Validating? For Whom Are We Validating? Preparing
SOPs & the Validation Master Plan. How Do We Plan & Program Validation?
Glossary. cGMP & Standards Related to Training & Education.