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

Overview:

Test Method Validation (TMV) is a critical yet often misunderstood requirement in the medical device industry. A key challenge lies in the role reversal between the test method and the product or process it is meant to assess. For instance, while achieving a defect-free process is the goal, a reliable test method must be equally adept at identifying defects and confirming the acceptability of good samples. This contrasts with process optimization, where the focus is on minimizing variability. TMV, however, centers on distinguishing between process variation and measurement errors inherent in the test method itself.

In many cases, new processes require the development of specialized test methods, which can lead to the conflation of process issues with those of the test method. This webinar will use case studies to illustrate how these challenges can be effectively 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 explicitly address method validation. Instead, it is indirectly referenced in areas such as equipment qualification, statistical methods, process validation, and design controls. Recent FDA warning letters have highlighted the increasing importance of method validation as a critical aspect of medical device validation. While traditional validation methods are well-established in chemical, microbial, and laboratory acceptance testing, they are often underutilized in the medical device sector. This session will bridge that gap, providing you with the necessary tools to ensure that your test methods are both reliable and compliant with current regulatory expectations.

Areas covered in the session:

• 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

Why should you attend?

In the highly regulated medical device industry, ensuring that your test methods are both accurate and reliable is not just a best practice—it's a regulatory necessity. As industry standards evolve and FDA scrutiny increases, the ability to effectively validate your test methods can make the difference between a product that passes inspection and one that faces costly delays or rejections.

This webinar will equip you with the knowledge and tools to navigate the complexities of Test Method Validation (TMV), helping you to avoid common pitfalls that could compromise the quality and compliance of your products. Whether you are involved in process development, quality assurance, or regulatory affairs, this session will provide you with actionable insights to enhance your TMV practices. Through real-world case studies and practical guidance, you will learn how to distinguish between process variations and measurement errors, ensuring that your test methods are robust and meet the highest standards of regulatory compliance.

By attending, you will gain a deeper understanding of the critical role TMV plays in the medical device lifecycle and how to apply the latest industry developments to your validation efforts. This is an essential session for professionals who want to stay ahead of the curve and ensure the success of their medical devices in today's competitive market.

Who will benefit?

This webinar is designed for professionals involved in the development, validation, and regulation of medical devices. Key roles that will benefit include:

• Quality Assurance Managers
• Quality Control Engineers
• Regulatory Affairs Specialists
• Process Development Engineers
• Validation Engineers
• Test Method Developers
• Compliance Officers
• Design Engineers
• Manufacturing Engineers
• Laboratory Managers
• R&D Scientists
• Medical Device Project Managers