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Note: Contents data are machine generated based on pre-publication provided by the publisher. Contents may have variations from the printed book or be incomplete or contain other coding.
Preface 1 Introduction 2 Regulations 3 Terminology 4 Risk 5 Master and Project Planning 6 Design Qualification 7 Installation Qualification 8 Operational Qualification 9 Performance Qualifiction 10 Software and Computers 11 Validation 12 Data Review 13 Out-of- Specifications 14 Certified Reference Standards 15 People 16 Proficiency Testing 17 Audits App A Glossary App B Testing App C SOP App D Books App E References Ludwig Huber, PhD Validation and Qualification in Analytical Laboratories, Second Edition
Library of Congress Subject Headings for this publication:
Chemistry, Analytic -- Quality control.
Chemical laboratories -- Standards.
Chemistry, Pharmaceutical -- standards.
Chemistry, Analytical -- standards.
Drug Industry -- standards.
Laboratories -- standards.
Quality Control.