R&Q and iuvo BioScience Webinar: Chemical Characterization Requirements

Original Webinar Description

This joint webinar was presented by Regulatory and Quality Solutions (R&Q) and iuvo BioScience is focused on the requirements for chemical characterization in the healthcare industry. Specifically, it discussed the standards required for ISO 10993-18 chemical characterization for medical devices and compare the ISO requirements with the pharmaceutical industry requirements and best practices for extractables and leachables testing.

The webinar explained the standards for both industries, discussed the testing methodologies required, and provided some case study experience from an E&L perspective. Participants learned:

  • Basic terminology used in these studies, the difference between an extractable and a leachable, and how these terms are used in the medical device and pharmaceutical industries
  • The chemical characterization requirements for both the medical device industry and pharmaceutical industry, and the implications for combination products
  • Basic parameters for when these studies are required and how they are set up, including some things to look out for when designing a study
  • Some real world case study experience from extractables and leachables testing


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