The workshop will focus on leachable risk assessment and therefore a pre-read package on the basics of extractable and leachable will be sent to delegates in advance of this course, enabling the workshop to devote more time on the technical risk assessment process.
The workshop is designed to give practical experience of performing a technical risk assessment to evaluate exposure risk to patients from leachables derived from container closure or manufacturing materials and then use extractable and/or leachable testing as risk reduction activities to meet regulatory expectations.
It will consist of a mixture of short presentations and predominately an interactive element performing a risk assessment on a fictitious medical product. The facilitators from Smithers Rapra, Baxter Healthcare and GSK will assist in the workshop and give the presentations.
The presentations will cover the concepts and themes associated with a science led risk based approach to extractable and leachable testing and its close alignment to concepts of quality by design and lifecycle management aligned to guidance of Drug Product Development (ICHQ8) and Quality Risk Management (ICHQ9). Interactive element will cover:
- Risk identification (cause and effect)
- Risk evaluation & analysis (knowledge gathering and scoring)
- Risk reduction (Extractable and/or leachable testing)
The workshop will run from 09:30 – 17:30 and will include lunch. Please ensure you include your role in extractables and leachables when booking your ticket so teams can be assigned with a diverse mixture of people.
Tickets for the workshop are $899 in addition to your conference ticket*.
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*Places on the workshop are limited so book early to avoid missing out. Your attendance at the workshop is subject to approval by the facilitator(s) and you must have booked a ticket to the 2-day E&L USA 2017 conference to be eligible to attend.