Leachable Risk Assessment: A structured approach to meet regulatory expectations

Tuesday 6th November: 9:30 - 17:30 (registration from 9am and lunch included)

Led by representatives from Smithers Rapra

The workshop will focus on leachable risk assessment and 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 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 cover the entire day 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.