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Validity : 29th Nov'24 to 09th Dec'24
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
- 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
Overview of the webinar
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.
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.
Who should attend?
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
Why should you attend?
This webinar 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.
Faculty - Mr.Jose Mora
Jose Ignacio Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full-time as a consulting partner for Atzari Consulting, Jose´ served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem-solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
Jose´ led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace, and lean manufacturing practices.