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?