Fr. 179.00

Validation in Thermal Analysis

English · Hardback

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Description

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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

About the author

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.

Summary

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

Product details

Authors Markus Schubnell
Publisher Hanser Fachbuchverlag
 
Languages English
Product format Hardback
Released 12.08.2022
 
EAN 9781569909065
ISBN 978-1-56990-906-5
No. of pages 276
Dimensions 214 mm x 20 mm x 302 mm
Weight 1223 g
Subjects Natural sciences, medicine, IT, technology > Technology > Chemical engineering

Werkstoffprüfung, Fertigungstechnik und Ingenieurwesen, VALIDATION, Werkstoffprüfung und Analytik, thermal analysis, measurement errors, Thermogravimetry, Interlaboratory studies, Instrument qualification

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