Implementation and Validation of Single-Use Processing Systems Using Quality Risk Management Approach

Single-use technologies (SUT) have evolved into commercial operations and drug manufacturers look for solutions to industrialize its usage in a safe and reliable way.

 

With single-use systems (SUS) adoption, quality ownership involves shared responsibilities between supplier and end user. Additional parts of the supply and quality chain shift to supplier.

 

Join us as we present existing good practices to ensure critical quality attributes (CQAs) of the SUS throughout their life cycle.

 

In this webinar, the fundamental principles of Quality Risk Management (QRM) applied to SUS adoption and validation will be discussed.  In addition, participants will gain an in-depth understanding of how to define an integrity strategy for their critical SUS, as well as on how to safely Pre-Use Post Sterilization Integrity Test (PUPSIT) filters in SUS.  By the conclusion of the session, all attendees should be able to define a risk mitigation strategy for SUS.

Moderator

 

 

Charlotte Masy

Hélène Pora

VP Technical Communication & Regulatory Strategy
Pall Biotech

 

Hélène has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in manufacturing, quality and regulatory aspects.  She has over 30 years of experience working for the biopharmaceutical industry, the last 29 years within Pall Corporation.

 

She speaks regularly at conferences about single-use technology with a strong focus on validation and overall process integration aspects. She is also involved in different industry interested group with a strong focus on BPOG, and she is sitting on the board of BPSA.

Speaker

 

 

catherine piton

Catherine Piton

Senior Marketing Manager

Pall Biotech

 

Catherine is Senior Marketing Manager within Technical Communication & Regulatory Strategy department of Pall Biotech, mainly responsible for the harmonization of single-use technologies manufacturing methods and their alignment with regulatory requirements. After a master degree in microbiology applied to risks and quality controls in pharmaceutical industry, she joined Pall Corporation in 2005 within scientific laboratories and services to occupy different roles such as rapid microbiology technical support manager for Europe and then project manager for validation services.

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Implementation and Validation of Single-Use Processing Systems Using Quality Risk Management Approach

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December 2020
Servicios de Validación de Filtración y Single Use Technology

Biotech | Pall Corporation 웨비나 시리즈

¡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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