2017 - Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Overview
Test 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 Attend
Although 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 Webinar
Test Method Validation - Overview
Quality System Regulation, 21 CFR Part 820, and ISO 13485 - Overview
When should Methods be validated?
Qualification vs. Validation
Types of Test Method Validations
How to perform successful test method validations
How to ensure your inspection of verification is effective
Detailing real-life case studies
Understanding global reference standards for test method validation
FDA requirements for TMV
How to prove your inspection method is repeatable and reliable
Recommendations: Some Best Practices and Strategies
Learning Objectives
This 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 Benefit
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Quality Engineers and Auditors
Manufacturing Engineers
Regulatory Affairs Teams
Quality Assurance & Quality Control Teams
Operations Teams
Document Control
Design Assurance Teams
Device Development Teams
Personnel involved in Verification and Validation planning, execution and documentation for devices
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