Implementing Single Use Technologies in Sterile Vaccines Processing

Implementing Single Use Technologies in Sterile Vaccines Processing

This on-demand webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.

One of the main challenges when considering single-use technologies in sterile vaccines manufacturing is to ensure the highest level of assurance of integrity and sterility.

 

This webinar presented by Charlotte Masy of GSK is a case study illustration of GSK’s strategic approach for sterility assurance.

 

 Topics covered:

 

  • How a Quality by Design (QbD) approach has been applied to develop, design and qualify single-use systems for vaccine manufacturing
  • How GSK manage sterility assurance concerns
  • Assessing and mitigating risks to integrity of SUS in sterile applications

 

Speaker

 

 

Charlotte Masy

Charlotte Masy

 

Technical Lifecycle Project Manager 

TLCM-MSAT

GlaxoSmithKline

Learn more about the Helium Integrity Test

Manage risk in your critical process with this high sensitivity, supplier integrity test for single-use systems, filling sets and mixer biocontainers

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December 2020
Servicios de Validación de Filtración y Single Use Technology

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¡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!

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