Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
Instructor:
Jose Mora
Product ID: 705692
Training Level: Intermediate
- Duration: 90 Min
Why Should You Attend:
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.
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.
Areas Covered in the 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
Who Will Benefit:
- 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
Jose Mora
Principal Consultant, Atzari Enterprises
Jose 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, José 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.
More Training By Experts
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