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· 제목 : Validation in Thermal Analysis (Hardcover)
· 분류 : 외국도서 > 기술공학 > 기술공학 > 품질관리
· ISBN : 9781569909065
· 쪽수 : 276쪽
· 분류 : 외국도서 > 기술공학 > 기술공학 > 품질관리
· ISBN : 9781569909065
· 쪽수 : 276쪽
목차
- Part 1: Validation of Computerized Systems
- Recent Changes in Regulations and Regulatory Guidance
- Instrument Qualification, Computerized System Validation and Method Validation
- Regulatory Requirements for Computerized System Validation
- Computerized System Validation
- Writing the User Requirements Specification (URS)
- Auditing the System Supplier
- Installation Qualification and Operational Qualification (IQ and OQ)
- Performance Qualification (PQ) or End User Testing
- Part 2: Method Validation
- Measurement Errors and Uncertainty of Measurement
- Validation of Analytical Procedures and Methods
- Interlaboratory Studies in Thermal Analysis
- Method Development Through to SOP
- Practical Examples
- Appendix 1: 21 CFR Part 11 and EU GMP Annex 11
- Appendix 2: Basic Statistics
- Appendix 3: Standard Test Methods for Thermal Analysis
