Requirements of Sterilizing Filtration Validation
Requirements of Sterilizing Filtration Validation
The landscape for manufacture of sterile medicinal products is evolving. Sterilizing filtration requirements are changing to reflect more complex fomulations. Expectations from regulatory authorities related to the evaluation of potential impurities or leachables for polymeric components with drug contact is also on the rise. We will share our updates on how we are working with end users to support them through these challenges.
Participants will learn about:
- Regulatory and reference guidelines for filter validation and extractables and leachables evaluation
- Typical filter validation tests
- A risk assessment decision tree for E&L evaluation
- A validation services process workflow
Speaker
Elisabeth Rizzo
Validation Project Manager
(Scientist II)
Elisabeth is a project manager within the European Validation team, supporting customers to document their Pall filter and single-use technology validation, to ensure their sterile manufacturing process will perform as intended in alignment with GMP requirements and industry guidelines.
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Biotech | Pall Corporation webinar series
¡Todo sobre los ensayos de validaciones para cumplir con los máximos estándares regulatorios!
Hablaremos sobre puntos cruciales de los servicios de validación, incluyendo:
1. Necesidad de validación
2. Cómo se realizan los ensayos de validación
3. Análisis de riesgo: re uso de filtros y toma de decisión en ensayos a realizar
4. Servicio de Validación Pall: documentación requerida para iniciar una cotización
¡No pierdas esta segunda oportunidad!