Recommendations: Some Best Practices and Strategies How to prove your inspection method is repeatable and reliable ![]() Understanding global reference standards for test method validation How to ensure your inspection of verification is effective How to perform successful test method validations Quality System Regulation, 21 CFR Part 820, and ISO 13485 – Overview 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. In numerous warning letters, we have witnessed significant importance of method validation as an applicable medical device validation activity. It alludes to it in equipment qualification, statistical methods, process validation, design controls, and other sections. Test Method ValidationĪlthough 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. ![]() This webinar will present case-studies to explore how those issues are addressed. 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. Those working on Test Method Validation, on the other hand, focus on discerning between process variation and measurement error from the test method itself. Those who work with process optimization and validation focus on optimizing a process and reducing variability. 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. A fundamental issue is the role-reversal between the test method and the product or process it is designed to detect. Test method validation is an often-confusing requirement for medical devices.
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