Webinars

Chemical Characterization and Toxicological Risk Assessments: A Smart Approach to Biological Evaluation

Wednesday, May 30, 2018 | 8am PDT | 11am EDT | 3pm GMT | 4pm CET

Upcoming changes to the general guidance for biocompatibility testing will soon dictate a new approach to biological risk assessment for all types of medical devices. Regulatory agencies will require a more rigorous Chemical Characterization as a prerequisite for biological risk assessment, followed by Toxicological Risk Assessments, to elucidate the need for further testing.

During this webinar, our experts will provide the framework for this new approach to biological evaluation, including:

• Regulatory guidance, including anticipated changes to ISO 10993 series of standards.
• How to design appropriate Chemical Characterization studies.
• Typical outputs for Chemical Characterization Testing.
• A basic framework for toxicological evaluations.
• Techniques used to reduce dependence on animal testing.

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View our Past Webinars

• Sterility Validation 101: Ensuring a robust sterilization validation program from start to finish
• Biocompatibility Testing of Combination Devices - New Regulatory Guidance
• Developing a Comprehensive Tool Kit for Microbial Identification
• Chemistry and Microbiology Perspectives on Cleaning Validations and Disinfectant Efficacy Studies
• Best Practices for Extractables and Leachables Testing