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OverviewThe 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. Full Product DetailsAuthor: Markus SchubnellPublisher: Hanser Publications Imprint: Hanser Publications Dimensions: Width: 21.50cm , Height: 2.00cm , Length: 29.90cm Weight: 0.556kg ISBN: 9781569909065ISBN 10: 1569909067 Pages: 276 Publication Date: 31 August 2022 Audience: Professional and scholarly , Professional & Vocational Format: Hardback Publisher's Status: Active Availability: In stock  We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately. Table of ContentsPart 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 AnalysisReviewsAuthor InformationDr. 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. Tab Content 6Author Website:Countries AvailableAll regions |
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