Validation in Thermal Analysis

ISBN-13: 9781569909065 / Angielski / Twarda / 2022 / 276 str.

Markus Schubnell

Spis treści

• 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

O autorze

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.