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Eurofins >> Medical Device >> Webinars & Events >> Webinars & Seminars >> Challenges in virus clearance studies design and execution for tissue-based medical devices to be submitted to US FDA

Webinars & Events >> Webinars & Seminars >> Challenges in virus clearance studies design and execution for tissue-based medical devices to be submitted to US FDA

Challenges in virus clearance studies design and execution for tissue-based medical devices to be submitted to US FDA

Challenges in virus clearance studies design and execution for tissue-based medical devices to be submitted to US FDA: How to overcome the challenge of very high Log reductions in input virus titer. Introduce the US FDA requirements of virus clearance for tissue-based medical devices for the US market and present two case studies:

Case study 1: where a stand-alone VC study was validated in order to achieve more than 6Log reductions in input virus titer
Case study 2: where multiple steps needed to be identified and validated in order to achieve very high Log reductions

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