Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
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Category bioanalytical method development;fda method validation
Deadline: June 21, 2017 | Date: June 21, 2017
Venue/Country: 2754 80th Avenue, New Hyde Park, NY 11040, U.S.A
Updated: 2017-05-26 15:17:12 (GMT+9)
Call For Papers - CFP
OverviewTest method validation is an often-confusing requirement for medical devices. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. For example, while a defect-free process is desirable, a test method must be reliable both in detecting defects and in not rejecting acceptable samples. Those who work with process optimization and validation focus on optimizing a process and reducing variability. Those working on Test Method Validation, on the other hand, focus on discerning between process variation and measurement error from the test method itself.Often, the test method for a new process must be designed specifically for that process, and some of the pitfalls are in confounding the process itself with the test method. This webinar will present case-studies to explore how those issues are addressed.Why Should You AttendAlthough the FDA provides guidance on method validation, the Code of Federal Regulations (CFR) Title 21 Part 820: Quality System Regulation (QSR) 21 does not specifically broach the topic of method validation. It alludes to it in equipment qualification, statistical methods, process validation, design controls, and other sections. In numerous warning letters, we have witnessed significant importance of method validation as an applicable medical device validation activity. Although, some traditional methods have been applied to chemical, microbial and laboratory acceptance testing methods, they are generally less utilized in the medical device industry.Areas Covered in this WebinarTest Method Validation - OverviewQuality System Regulation, 21 CFR Part 820, and ISO 13485 - OverviewWhen should Methods be validated?Qualification vs. ValidationTypes of Test Method ValidationsHow to perform successful test method validationsHow to ensure your inspection of verification is effectiveDetailing real-life case studiesUnderstanding global reference standards for test method validationFDA requirements for TMVHow to prove your inspection method is repeatable and reliableRecommendations: Some Best Practices and StrategiesLearning ObjectivesThis medical device process validation training will help you better understand Test Method Validations to verify the performance of a Medical Device, global reference standards, the FDA requirements and how to perform successful TMV to ensure your inspection of verification is effective, using detailed real-life case studies.Who Will BenefitManagers, Supervisors, Directors, and Vice-Presidents in the areas of:Research & DevelopmentQuality Engineers and AuditorsManufacturing EngineersRegulatory Affairs TeamsQuality Assurance & Quality Control TeamsOperations TeamsDocument ControlDesign Assurance TeamsDevice Development TeamsPersonnel involved in Verification and Validation planning, execution and documentation for devicesFor more detail please click on this below link:http://bit.ly/2qiWXEmEmail: referralscomplianceglobal.usToll Free: +1-844-746-4244Tel: +1-516-900-5515Fax: +1-516-900-5510
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