September 26, 2018   
Gillette Stadium

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Simplifying Single Use Technology (SUT)

4:30 PM – 5:30 PM |

Simplifying Single Use Technology (SUT) implementation is achievable. Using a cross functional panel of SUT end users (Shire, Sanofi, Homology), SUT suppliers (Saint Gobain) and SUT subject matter experts (PDS), this presentation will provide SUT simplification guidance from such perspectives as Process Engineering, Supply Chain/Materials Management, Quality Assurance/Quality Risk Management, Process Development and Validation/Materials Qualification. Attendees will be provided guidance on numerous strategies to simplify SUT implementation for both new and existing facilities.

This presentation will provide attendees valuable guidance and strategies including:

  • Simplification of SUT through site specific standardization
  • Developing simplified and relevant SUT requirements
  • Strategies to simplify Materials Management/Supply Chain for SUT
  • Simplifying SUT program deployment using a phased product stage rollout
  • Simplifying the impact of SUT Vendor Change Notifications (VCNs)

Every presenter will have one or more case studies to support their simplification strategy.

Panelist Moderator: Mark McElligot | Partner/Principal Process Engineer, Process Design Solutions Sandbox

With over 20 years of SUT experience, Mark McElligott has engineered and deployed SUT solutions accompanied by defendable, integrated SUT programs. Mark is a Partner and Principal Process Engineer with Process Design Solutions and PDS Sandbox.

 

Panelists:

Polly Hanff | Global Regulatory Affairs & Quality Director, Saint-Gobain Performance Plastics

Polly Hanff has more than 15 years of experience working in the pharma industry which she leverages in her role is the Global Regulatory Affairs and Quality Director at Saint-Gobain Performance Plastics where she has overall responsibility to assure the quality and compliance of single-use systems.

 

 

Mark Maselli | Engineering Manager, Homology Medicines

Mark Maselli is the Engineering Manager, responsible for the design, implementation, and support of single-use technologies at Homology Medicines, Inc.  He has expertise in the design, development, and maintenance of single-use technologies, as an end-user in the biotechnology industry for over 6 years.  Previously, he worked as a Process Engineer and Program Manager, specializing in single-use technologies, manufacturing operations, and polymer extrusion.  He holds a Bachelor of Science in Chemical Engineering and a Master of Science in Engineering Management.  His experience, single-use knowledge, and education, gives him a personal working knowledge of the application and implementation of single-use technologies in the biotechnology industry.

Jay Harp | Single-Use Product Manager, Integra Companies LLC

With over 15 years of SUT experience, Jay Harp has engineered custom SUT products for companies around the world. Jay has intimate experiences with SUT systems in Upstream and Downstream processes. Jay is currently the Single-Use Product Manager for Integra Companies, LLC and also an active member of the ASME-BPE and BPSA.

 

 

Bill Devine | Senior Process Engineer and Project Manager, Pharma-Tech Process and Facility Services, Inc.

Bill Devine is a Senior Project Manager at Pharma-Tech Process and Facility Services, Inc.  Bill has over 20 years of diversified experience in the engineering, construction, start-up, qualification, operation and management of pharmaceutical and biotechnology manufacturing facilities, systems and equipment.  Like many, Bill evolved growing up with traditional stainless steel aseptic processing systems (tanks, piping, CIP, SIP) operating within controlled cleanroom environments,  and he has spent the last 10 years assisting customers navigate technology transfer and process development towards more efficient single use (disposable bags, tubing) and hybrid systems for the manufacture of pharmaceutical and biological drug products.

Bill is known to drive and deliver complex projects across large cross-functional organizations by identifying well-defined project user requirements and achieving them with detailed project execution plans and implementation strategies.  He leverages both engineering best practices and science and risk based principles to accelerate timelines throughout the entire project lifecycle.   His extensive field experience consulting as an owner’s rep and being a supplier himself brings a unique perspective and balance to projects, as he enables effective communication and work streams that are required with an increasing use of external suppliers as a result of adopting single use systems.