Pathways To Success: Expert Insights on Single-Use Technology
Webinar Details
- Duration
- 60 min
Summary
As single-use technologies have been widely adopted by the pharmaceutical industry, there has been a corresponding shift in responsibility from end-users to suppliers.
In order to meet quality, regulatory and technical requirements a large quantity of information on product specifications, validation and compliance has to be exchanged between supplier and end-user.
Join this webinar from experts at Pall Corporation to discuss how industry collaboration and digitalization are helping to meet these challenges.
You will learn:
• The key touchpoints in the single-use system project life cycle between suppliers and end-users
• How the Pall ACMS system supports a QbD approach at over 300 biomanufacturer’s sites, providing instant access to key information and reports aligned with the BioPhorum Single Use User Requirement package
• How design flexibility is supported by the ACMS while maintaining strict validation, improving continuity of supply
• Real world examples of how digital tools enabled company-wide standardization of SUS
Speakers
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Presenter
Hélène Pora
VP Technical Communication & Regulatory Strategy
Pall CorporationHélène has been instrumental in the development of Pall single-use technologies for the last 25 years, while getting heavily involved in manufacturing, quality and regulatory aspects. She has over 35 years of experience working for the biopharmaceutical industry, the last 30 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 interest groups with a strong focus on BioPhorum, and BPSA.
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Presenter
Kevin Thompson
Senior Technical Director, Pall Advanced Separation Systems (PASS)
Pall CorporationKevin is a Technical Director within the PASS team - a customer-focused process engineering and project management team responsible for delivering integrated solutions to the pharmaceutical industry. He has spent the last 40 years in Engineering, starting in the UK’s electrical supply industry, transitioning to Oil and Gas, followed by Chemicals and Polymers, with the last 22 years dedicated to Pharmaceuticals. He is located within our Center of Excellence in Portsmouth, UK, where he manages a group of project managers - process and commissioning engineers supporting global projects. His team was dedicated to the Astra Zeneca /Oxford COVID-19 vaccine project where their involvement started in the early process development phase, through to delivery.
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Presenter
Peter Hiskey
Senior Technical Director, Biotech - Application Engineering
Pall CorporationPeter leads the Pall Biotech Application Engineering Team and is located within our Centre of Excellence in Portsmouth, UK. One of Peters key responsibilities is the design development and management of the global ACMS system, which is the primary in-house tool used to manage and control Pall’s Single Use Technology business. Peter manages a team of software engineers, validation engineers, QA test engineers, material science engineers, master data controllers and system administrators/analysts.
Through his career Peter has worked in a variety of industries including Biopharm, Chemical and Polymer, food and beverage and Oil exploration. He joined Pall in 2006 and in 2008 started working closely with the single use technology business, he soon realized the lack of suitable tools in the marketplace to create and manage SUT products lead Peter to start the ACMS development.
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