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E&L Online Post-Event 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 a post-event E&L 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

Regulatory – ISO 10993-18, FDA

  • Regulatory structure
  • ISO 10993, ISO18562 FDA and EMA
  • Thresholds

Chemical Characterisation, Extraction, Leachables

  • Best practices – general consensus
  • Study design – Hypothetical chemical release, exhaustive extraction, leachables etc.
  • Case studies

Results Interpretation

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