Validation in Thermal Analysis
portes grátis
Validation in Thermal Analysis
Schubnell, Markus
Hanser Publications
08/2022
276
Dura
Inglês
9781569909065
15 a 20 dias
Descrição não disponível.
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
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Computerized System Validation; Method Validation; Thermal Analysis; equipment Validation; process validation
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
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
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
