Global Regulatory Requirements for Chemical Characterization: How to Cost-Effectively Demonstrate Biological Safety

Release Date
July 12, 2018 10:00 - 11:00 AM U.S. ET

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Medical device organizations that manufacture products that involve patient contact are almost always required to perform some level chemical characterization evaluation, per ISO 10993-18, to ensure end-user safety. Depending on a device’s intended clinical use, chemical characterization – specifically, extractable/leachable testing – may be required by various regulatory agencies to address biological safety. However, utilizing this type of testing methodology to address various updates to medical devices can prove to be a cost-effective way to assess device changes and their potential impacts to biological safety.

Join us for our webinar on July, 12, 2018, with NAMSA biological safety expert, Duane Mancini, to learn about global regulatory requirements for chemical characterization testing and how manufacturers can use chemical characterization to demonstrate biological safety for their devices.

Discussed will be:

Time will also be allotted for discussion of real-world case studies and Q&A.

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About the Presenter:
Duane Mancini, Senior Technical Advisor

Duane Mancini currently serves as a Senior Technical Advisor at NAMSA where he oversees Analytical Chemistry and Biological Safety programs. Throughout his career, Duane has held various positions within analytical chemistry, small-molecule synthetic chemistry, and large-scale synthetic chemistry. He is an active member in the American Chemical Society (ACS) and the American Association for the Advancement of ‘s Science (AAAS). Duane holds a Master of Science in Medical Chemistry and a Bachelor of Science in Pharmaceutical Sciences, both from the University of Toledo (Ohio).