Overview

JOIN WEBINAR: https://factglobal-org.zoom.us...

Technical Support: [email protected] or 402-920-7001

This FREE webinar is the curtain opening of FACT Audit and Assessment Services, a solution provided by FACT Consulting. Cell and gene sponsors, license holders, manufacturers, registries, collection sites, processing laboratories, and treatment sites are invited to learn how this solution increases the return on investment in site assessments via specific, high-value benefits.   

As reported extensively, the current industry qualification and auditing approach for cell and gene therapies is unsustainable and may delay or prevent patient access. FACT Consulting confirmed via a recent pilot project that its services can rapidly assess accredited and non-accredited sites’ ability to participate in a company’s network, perform assessments on behalf of industry, and reduce the duplicative audit burden on healthcare sites while increasing the quality of their services. It is a win-win-win solution that reduces the audit burden on industry and sites, allowing them to serve more patients.

At the conclusion of this live activity, participants will be able to: 

• Explain why FACT Audit & Assessment Services benefit industry and accredited and non-accredited healthcare institutions. 

• Discuss the FACT assessment process and deliverables provided to clients and assessed sites. 

• Evaluate the Voice of the Customer’s experience with the pilot assessments from the perspective of industry and cell collection sites. 

• Provide guidance on how to initiate assessment services and obtain institutional approval to leverage reports.

Speakers

Kim Kasow, DO

SVP, Medical & Quality Services

NMDP

Kimberly Kasow, DO

Kimberly Kasow, DO, serves as the Senior Vice-President of Medical and Quality Services at the NMDP within the Department of Operations, and oversees the medical management of NMDP donors. Previously, Dr. Kasow was Director of the Pediatric Bone Marrow Transplant Program at the University of North Carolina at Chapel Hill and held positions such as Associate Director of Quality Initiative for the UNC Bone Marrow Transplant and Cellular Therapy Program, Medical Director of the Marrow Facility, and Associate Director of Quality for the UNC Lineberger Advanced Cellular Therapeutics Facility—an independently FACT-accredited, more-than-minimal processing entity.  Currently, Dr. Kasow is an Adjunct Professor at UNC. Dr. Kasow has been a FACT Inspector since 2006 and has contributed to numerous FACT committees. She is honored to currently serve as Chair of the Quality Management Committee. She remains actively involved in FACT initiatives, including the Quality Management webinar series, Boot Camps and Inspector Training.

Nothing to disclose.

Liz Ferraro

Manager, FACT Audit & Assessment Services

FACT

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Nick Tsourides

Director of Quality & Compliance

Johnson & Johnson

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Diane Bullock

Quality Manager, Stem Cell Transplant & Cellular Therapy Program

University of Rochester Medical Center | Strong Memorial Hospital

Diane Bullock is the Quality Manager for the Stem Cell Transplant & Cellular Therapy Program at the University of Rochester Medical Center, Strong Memorial Hospital in Rochester, NY.  She has a medical technologist background with 20+ years of experience maintaining compliance with regulatory agencies such as the FDA, NYSDOH and FACT.

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