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Volunteer Opportunity for Round Table Discussion on Single-Use Supply Crisis

Disposable CoP Steering Committee
Volunteer Opportunity for Round Table Discussion on Single-Use Supply Crisis

COVID-19 has caused disruptions and delays with supply chain all across the world. Single-Use technologies (SUT) play a vital role in manufacturing of pandemic vaccines and have drastically reduced the typical vaccine development and manufacturing production timelines. The pandemic has further increased the sourcing demands for SUT. This non-forecasted demand has led to extended lead times or even shortage scenarios. The ISPE Disposable (Single-Use) Community of Practice (CoP) is organizing a round table on Thursday 2 September to discuss the "Single-Use Supply Shortage Crisis".

The goal will be to share good and bad experiences, to identify bottlenecks and discuss improvement strategies to secure SUT supply. We are looking for ISPE members with the following areas of expertise:

  • Supply Chain/ Procurement: SMEs with experience in supply chain/procurement dealing with challenges specific to SUT
  • Operations (GMP Manufacturing): SMEs with experience in manufacturing in a GMP environment including single-use upstream and downstream equipment for Operations
  • MS&T: SMEs with experience in manufacturing sciences and technologies including scaling up/down of single-use systems
  • Process Engineering: SMEs with experience in process engineering with design and CQV (commissioning, qualification, or validation) of facilities equipped with single-use equipment
  • Regulatory Compliance: SMEs that are experienced and well versed with regulatory compliance and international regulations and challenges of disposable systems
  • Quality: Quality professionals with experience in approving qualification documentation and giving direction on GMP release of single-use equipment

To provide adequate balance, we are looking for participants from user side, supplier side, and service providers. If you would like to be considered as a participant for the round table, please forward your contact details, including email, your area of expertise, and brief description of why you would be well suited to Communities@ISPE.org.

The round table discussions will be moderated by members of the Disposable CoP Steering Committee. It will be a virtual event and you may participate regardless of geographical location.

Single-Use Supply Shortage Roundtable discussion
2 September 2021
11:00 am – 12:30 pm ET 

Learn More


Disposable CoP Steering Committee:

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Dharti Pancholi
Chief Operations Officer
Advent Engineering Services Inc
Chair
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Javier Lozano
Process Engineering Technitian
Lonza Biologics Porrino
Co-Chair
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Addison J. Raine, E.I.T.
Senior Process Engineer
IPS
Secretary
Katell Mignot-Moraux
Subject Matter Expert Single-Use Technology
Sartorius Stedim FMT S.A.S.
David AR Wolton
Biopharma Consultant
PM Group
Adam S. Goldstein
Senior Director R+D/SUT
Thermo Fisher
Pietro Perrone, PE
Sr. Project Engineer, Automation Applications
Cytiva
Christopher J. Smalley
Compounding Pharmacist Advisor
ValSource
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Jeff Lewis
Assoc. Director, Global Procurement
Takeda Pharmaceuticals
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Cristina Van Loy
Senior Manager, Environmental Sustainability
Thermo Fisher Scientific
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Changhong Zhang
Associate Director
Sanofi
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Esmaeil Ektefaie, Sr.
Quality
Shire - Vienna
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Swapnil Ballal
Managing Partner
Q-Exl Partners