Online Workshop: Extractables & Leachables for Medicinal Products

Date: Thursday 22 September 2022

Time: 13:00-17:00 BST

Location: Online

Price: Tickets: €349 + VAT

"As always, Smithers delivered an organised, professional workshop with interesting and relevant presentations"
- Analytical Expert, Novartis

Workshop Agenda

13:00 Introduction to Extractables and Leachables

Origins of E&L
Terminology

14:00 Regulatory - FDA; EMEA etc

Regulatory structure
PQRI, USP
Dose and risk
Thresholds

14:45 Break

15:00 Chemical characterisation, Extractables, Leachables

A bit about medical devices
Extractables assessments
Leachables and simulations
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

"Very informative introduction to E&Ls, I took a lot from the workshop and there is a lot I am looking forward to going back over"
- Senior Analytical Scientist, Viatris/Mylan