Test Method Validation to Verify your Device Performance

OVERVIEW

This webinar will help you have an understanding of 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.

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. 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.

 

LEARNING OBJECTIVES

• 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

AREAS COVERED

• 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?

• 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

SPEAKER

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.

Others Details

Time: 01:00 PM EST| 10:00 AM PST