Join us for the On Demand Webinar for

Quality Assurance for
Single-Use Systems

Webinar On Demand! Register to watch now!

Duration:: 2 hours

Implementation and Validation of SUS using QRM

1. Implementation and Validation of SUS using QRM (1 hour

2. Integrity of SUS: Leak Testing and HIT^TM technology (1 hour)
PUPSIT for filters in SUS

1. PUPSIT for filters in SUS (1 hour)

2. Standardized Extractables Testing for SUS (1 hour)

Summary

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.

Speakers

Moderator:

Helene Pora
Pall Biotech
VP Technical Communication & Regulatory Strategy

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:

Sarah Jeffkins

Pall Biotech
Laboratory Manager

Sarah Jeffkins has been working in the Biotechnology Industry since 1988 when she joined Beecham Pharmaceuticals (now GSK) as a Fermentation Analyst.

During her 29 years working for GSK, she has undertaken a variety of roles within Upstream Operations (Fermentation), Downstream Processing (Extraction & Purification), Analytical and Quality. Sarah also had a role as Analytical Team Leader within a Technical Group where she developed her skills for managing a team, motivating and developing people whilst meeting tough objectives.

Sarah became the manager of the Analytical Laboratory at Pall Harbourgate facility in 2018, where she co-ordinates the extractable and leachable testing for Europe.
Speaker:

Catherine Piton

Pall Biotech
Senior Marketing Manager

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.
Speaker:

Patrick Evrard

Pall Biotech
Senior Principal Engineer

Patrick Evrard joined Pall Biotech in 2017, as Senior Director, SLS Single-Use Technologies, to manage the technical team providing expert technical support to Pall Biotech's customers. Before joining Pall, he led for more than 10 years a global technical team in charge of developing and implementing single-use technologies in GSK Vaccines' commercial manufacturing operations. Patrick and his team implemented at global level single-use technologies in critical sterile applications and re-engineered several vaccines processes, switching from classical grade A open processes to closed systems.
Speaker:

Alain Vanhecke

Pall Biotech
Senior Technical Specialist

Alain Vanhecke is a senior technical specialist for Pall Biotech based in Hoegaarden, Belgium. With over 33 years of experience in the bioprocessing industry, Alain is a critical driver of the extensive support program Pall provides for customers. He is responsible for multiple facets of integrating the bioprocess portfolio with scientific and laboratory services, including process development for strategic accounts and technical field support for the single-use technology portfolio in the European and Western regions.