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· 제목 : Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries (Hardcover, 2) 
· 분류 : 외국도서 > 기술공학 > 기술공학 > 품질관리
· ISBN : 9780849395291
· 쪽수 : 1144쪽
· 출판일 : 2006-05-30
· 분류 : 외국도서 > 기술공학 > 기술공학 > 품질관리
· ISBN : 9780849395291
· 쪽수 : 1144쪽
· 출판일 : 2006-05-30
목차
Introduction to Validation. Fundamentals of Validation SOPs. Validation Glossary. Calibration of Instruments. Training on the Job. Guidelines for Area Classification and Air Handling. Validation of a Steam Sterilizer. Kneading Machine. Blistering Machine. Installation Qualification of Computerized Equipment. Validation of Microbiological Methods. Vendor Certification. Facility Qualification. Recommended Reading.
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