Validation in Thermal Analysis
Validation in Thermal Analysis
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- ISBN: 978-1-56990-907-2
- Erscheinungsdatum: 08/2022
- Seitenanzahl: 276
- Auflage: 1
- Barrierefreiheit: Carl Hanser Verlag is currently unable to provide this document in an accessible format according to the standards. However, the structure of the text elements already largely complies with accessibility requirements. Carl Hanser Verlag is continuing to w
- Sprache: Englisch
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Carl Hanser Verlag GmbH & Co KG
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Produktinformationen "Validation in Thermal Analysis"
The validation of equipment, processes and methods is a basic requirement that nowadays has to be met in most industries. This handbook deals with the validation of computerized systems in general as well as with analytical method validation. The many detailed practical examples focus on thermal analysis of materials, such as plastics and rubber.
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
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Markus Schubnell
Dr. Markus Schubnell is a Thermal Analysis Application Specialist at Mettler-Toledo International, Inc., Switzerland. He coordinated the 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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