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Online Workshop: Extractables & Leachables for Medical Devices

Date: Tuesday 9 November 2021

Time: 13:00-16:00 GMT

Location: Online

Price: Tickets: €349 + VAT

Workshop Agenda

13:00 Introduction to Extractables and Leachables

  • Origins of E&L
  • Terminology

13:45 Regulatory - ISO 10993-18, FDA

  • Regulatory structure - devices vs. medicinal products
  • ISO 10993, ISO 18562, FDA and EMA (MDR)
  • Thresholds
  • Combination products

14:45 Break

15:00 Chemical characterisation, Extractables, Leachables

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

16:00 Experimental

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

Workshop Leaders

EL-EU-2021-P-Cummings-Workshop-Card
EL-EU-2021-K-Scott-Workshop-Card
EL-EU-2021-C-Bellis-Workshop-Card-NEW