Design an Effective Chemical Characterization Study for Your Device

Wednesday, May 15, 2024 
2pm-3:30pm ET / 1pm-2:30pm CT / 11am-12:30pm PT

Design an Effective Chemical Characterization Study for Your Device
The live event is over and a recording will be available soon.

PART A

Initiating a Successful 10993-18 Chemical Characterization Study

Summary: Outline of the process for starting a 10993-18 Chemical Characterization Study including common complications and ways to mitigate them. Tips for finishing a study on time, on budget, and sufficient to support a toxicological assessment.

Presenter: Philip Ferko, Ph.D., Senior Scientist, EAG Laboratories

PART B

Completing a Successful 10993-18 Chemical Characterization Study

Summary: Overview of the timeline for a 10993-18 Chemical Characterization Study, important milestones, potential complications, and ways to be ready for them. With a strong foundation and good communication, the study for any device can be completed according to plan.

Presenter: Philip Ferko, Ph.D., Senior Scientist, EAG Laboratories

Benefits of Planning a Study with a Toxicologist

Summary: How to position your medical device for success in a regulatory submission by including a Toxicologist in the planning stages of your Chemical Characterization Study including test article selection, decision-making on extraction conditions, proposal and protocol review, interpreting and best implementing feedback from regulatory reviewers, and derivation of an Analytical Evaluation Threshold for the extraction study.

Presenter: Melissa Badding, Ph.D., DABT, Senior Managing Scientist, Exponent

How to Deal with Data from a Study

Summary: How toxicologists work with chemists to help you best utilize and refine the resulting data from your Chemical Characterization Study such as addressing incompletely identified compounds. Learn best practices for evaluating very large datasets and unexpected findings such as the presence of perfluorinated compounds, nitrosamines, and carcinogens.

Presenter: Megan Arnold, Ph.D., Senior Scientist, Exponent

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