Register Interest

Extractables & Leachables for Medical Devices - Online Workshop

Date: Wednesday 17 February 2021

Time: 13:00pm - 17:00 GMT

After this years E&L Europe 2020 Online event we are excited to announce we will be running an Extractables & Leachables for Medical Devices post-event workshop online.

Led by esteemed experts; Tim Hulme, Principal Consultant at Smithers and Keith Scott, Senior Project Manager at Smithers.

Agenda

Introduction to Extractables and Leachables

  • Origins of E&L
  • Terminology

Regulatory – ISO 10993-18, FDA

  • Regulatory structure - devices vs. medicinal products
  • ISO 10993, ISO18562, FDA and EMA (MDR)
  • Thresholds
  • Combination products

Chemical Characterisation, Extraction, Leachables

  • Best practices
  • Study design – Hypothetical chemical release, exhaustive extraction, leachables etc.
  • Toxicological evaluation – where does this fit in?

Experimental

  • Techniques: GC-MS/LC-MS/ ICP/SH GC-MS etc.
  • Interpretation of results
  • Method development/validation
  • Dealing with unknowns
  • Toxicology again

Missed the workshop?

Purchase an on-demand ticket and gain full access to the workshop recording, as well as the presentations!

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