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

Description

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.

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

Areas Covered:

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 Should Attend:

Research & Development Departments
Quality Assurance Departments
Engineering Departments
Quality Control Departments
Manufacturing Departments
Regulatory Affairs Departments
Operations Departments
Documentation Departments
Design Assurance Teams
Device Development Teams
Personnel involved in Verification and Validation planning, execution and documentation for devices