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

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. 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.

Attend this webinar to understand when the method to be validated, validation vs qualification and all FDA requirements of test method validation and most importantly how to perform test method validation and ensure your inspection of verification is effective.

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