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

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Deadline: May 02, 2019 | Date: May 02, 2019

Venue/Country: U.S.A

Updated: 2019-04-05 16:24:32 (GMT+9)

Call For Papers - CFP

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. This webinar will present case-studies to explore how those issues are 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 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.