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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

If Something Looks Clean, Is It Really Clean? Cleaning Validations for Reusable Devices

Published Date: June 11, 2020

Presenter: Dr Lise Vanderkelen (Department Head Micro & Pharma Services Nelson Labs Europe)

Reprocessing validations of reusable medical devices have been overlooked for quite some time. But the upcoming MDR requirements and US FDA Scrutiny over reusable medical devices has shed a light to their importance and significance. The presentation will highlight some of the key aspects of what is required for validation studies for these type of devices and how to perform these validations. During her presentation, Lise Vanderkelen mainly focuses on cleaning validation for reusable devices. This presentation was recorded on 05 March at our Open House event.

Lise Vanderkelen

Lise Vanderkelen

PhD
Pharmaceuticals and Microbiology Expert

Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...

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