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.
Introduction to Extractables and Leachables
- Origins of E&L
Regulatory – ISO 10993-18, FDA
- Regulatory structure - devices vs. medicinal products
- ISO 10993, ISO18562, FDA and EMA (MDR)
- Combination products
Chemical Characterisation, Extraction, Leachables
- Best practices
- Study design – Hypothetical chemical release, exhaustive extraction, leachables etc.
- Toxicological evaluation – where does this fit in?
- Techniques: GC-MS/LC-MS/ ICP/SH GC-MS etc.
- Interpretation of results
- Method development/validation
- Dealing with unknowns
- Toxicology again