RQ IUVO Webinar ISO 10993-18 Extractables and Leachables

What?

This joint webinar 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 will discuss 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 goals for this webinar are to explain the standards for both industries, discuss the testing methodologies required, and provide some case study experience from an E&L perspective. You can register here.

More precisely, you will learn:

  • 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

When?

Thursday, October 20
1:00 - 2:00pm EST

Who?

The session will be presented by:

Chris Houston Director of Analytical Chemistry iuvo BioScienceChristopher Houston
Director of Analytical Chemistry
iuvo BioScience

 

Christine Santagate Regulatory and Quality SolutionsChristine Santagate
Client Solutions Advisor, RAC
R&Q

 

And remember, the recording and webinar slides will be made available to anyone who signs up!

Register Now

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