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Validation in Thermal Analysis / Markus Schubnell

By: Contributor(s): Resource type: Ressourcentyp: Buch (Online)Book (Online)Language: German Series: Hanser eLibraryPublisher: Munich : Hanser, 20220808Description: 1 Online-Ressource (274 Seiten)ISBN:
  • 9781569909072
Subject(s): Additional physical formats: 9781569909065 | Erscheint auch als: Validation in thermal analysis. Druck-Ausgabe Second edition. München : Hanser, 2022. 274 SeitenDDC classification:
  • 543.26 23/ger
RVK: RVK: VG 7101DOI: DOI: 10.3139/9781569909072Online resources: 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 AnalysisSummary: Dr. Markus Schubnell is a Thermal Analysis Application Specialist at Mettler-Toledo International, Inc., Switzerland. He coordinated this writing of this book with support form several colleagues in the Materials Characterization Support Group at Mettler-Toledo, and from industry and academic experts elsewhere.PPN: PPN: 1815692030Package identifier: Produktsigel: ZDB-16-HEB | ZDB-16-HEP | ZDB-16-HEB
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