Event Information

Event Topic:
Strategies for Assessing Unknowns: Simulated use testing, identification, or pen and paper justification?

Event Description:
Extractable compounds with unknown identities are a common problem when conducting a chemical characterization study in support of medical device biocompatibility. With increasing instrument sensitivity, regulatory scrutiny, and the widespread adoption of the Analytical Evaluation Threshold (AET), unknown compounds are being seen in increasing number in many studies. Many manufacturers struggle to address and mitigate the risk of unknowns. This presentation outlines strategies for addressing these unknowns including additional testing, including simulated use testing or identification of the unknowns, as well as a pen and paper justification.

Date/Time:
Date(s) - 12/08/20
8:30 am - 10:30 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/85043660945:

Speaker Information

Event Speaker:
Chris Pohl

Event Speaker Title:
Associate Technologist

Event Speaker Company:
Nelson Labs

Event Speaker Bio:

Christopher Pohl is a subject matter expert in toxicology and biocompatibility testing for medical devices. Chris has over six years of broad experience and training in what is required to support medical device biocompatibility including traditional in vivo and in vitro tests, extractable/leachable analytical chemistry testing, and toxicological risk assessment. His Bachelors in Material Science and Engineering from Boise State University was focused on Biomaterials and how to use them to support medical device development. Mr. Pohl worked for multiple medical device companies serving in many different roles. He has also worked for startup companies doing design engineering, project management, and supporting the marketing team. Mr. Pohl has experience with large animal studies and custom small animal studies and was a biocompatibility SME for Fresenius Medical Care supporting the design and development of products for hemodialysis and peritoneal dialysis At Nelson Labs, Mr. Pohl is responsible for consultations regarding biocompatibility, Biological Risk Assessments, Toxicological Risk Assessments, and extractable/leachable chemical characterization.

Event Details

Cost:
$0

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