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
Missed our event? Fill out the form below to view a recording of the presentations.
Design an Effective Chemical Characterization Study for Your Device
Join us for this live online symposium presented by EAG Laboratories and Exponent!
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
Missed our event? Fill out the form below to view a recording of the presentations.