Validation in Thermal Analysis
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- ISBN: 978-1-56990-906-5
- Buchangaben: 1. Auflage, 08/2022
276 Seiten, Fester Einband
The handbook is intended for newcomers interested in the theoretical and regulatory aspects of validation and for thermal analysis practitioners who have to validate their equipment and methods.
Contents:
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
The handbook is intended for newcomers interested in the theoretical and regulatory aspects of validation and for thermal analysis practitioners who have to validate their equipment and methods.
Contents:
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
Dr. Markus Schubnell is a Thermal Analysis Application Specialist at Mettler-Toledo International, Inc., Switzerland. He coordinated this writing of this book with support from several colleagues in the Materials Characterization Support Group at Mettler-Toledo, and from industry and academic experts elsewhere.
Dr. Markus Schubnell is a Thermal Analysis Application Specialist at Mettler-Toledo International, Inc., Switzerland. He coordinated this writing of this book with support from several colleagues in the Materials Characterization Support Group at Mettler-Toledo, and from industry and academic experts elsewhere.
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