- Qualification of process stream contact materials including single-use technologiesand packaging materials.
- Extractables & Leachables compliance remediation strategy development, execution, implementation and realization.
- Container closure intergrity test, Extractable and Leachable (E&L) test methods development and validation.
- Strategy development for process contact and packaging material changes and specification changes.
- Analytical laboratories (CRO) managements and technical assessments.
- Risk ranking / assessment model design.
- Shipping cold chain and container qualification
2nd Annual Extractables &
Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
Leachables Summit 2020
- 22 Oct 2020
Day 1: Thursday, 22 October 2020
CASE STUDY: BPOG’s extractable recommendation – the final chapter.