Meet Our Consultants

Tracy Dodd  |  Federico Rodriguez  | Sue Armitage  | Nancy Collins  | Deborah Griffin  | Linda KelleyRobert Rifkin  | Jean Sanders  | Carolyn Taylor

Deborah Griffin, MSc, ASQ, CPGP

Debe has over 20 years of experience in cellular therapy and laboratory science, including both minimally and more-than-minimally manipulated products. Deborah has been a FACT inspector for over a decade and has performed almost 20 external inspections. In addition, she was responsible for the FACT inspections of three independently accredited facilities at UPMC, the adult hematopoietic stem cell lab, the pediatric hematopoietic stem cell lab and a dendritic cell vaccine production facility, and successfully led them through 10 inspections. She is very active in ISCT including Chair of the North America Legal and Regulatory Committee. Deborah was formerly the Director of Quality Management for Cell Therapies of the Cell Therapies Facility at Moffitt Cancer Center in Tampa, FL, USA. Prior to that position, she served as the Manager of Quality Assurance and Regulatory Affairs for Cellular Therapy, and was responsible for three cGMP compliant and FACT accredited cellular therapy facilities at the Hillman Cancer Center, University of Pittsburgh Medical Center, in Pittsburgh, PA, USA.

Areas of Expertise

Quality Systems, Quality Indicators, Quality Management Plan; FACT, CAP and cGMP compliance; Facility and workflow planning; Document control and writing including policies, procedures, processes, facility master files, gap analyses, abstracts, posters, scientific publications, and IND and CMC preparation; staff training, coaching and mentoring; translational research; and qualification, verification and validation.

Scope of Experience

18 years of benchtop laboratory experience
10 years of quality and regulatory experience
13 years of management experience

Market Sector Focus

Hematopoietic stem cell collection and processing (bone marrow, apheresis product, cord blood)
Immunotherapy processing (dendritic cells, T cells, therapeutic cell lines, tumor infiltrating lymphocytes)
Adipose processing (stromal cells)
Liver processing (hepatocytes)
Vertebral column processing (bone marrow)
Bone marrow collection and processing for cardiac indications

Relevant Assignments

  • Performed more than 20 FACT cell processing laboratory inspections
  • Member of FACT Quality Committee
  • Member of FACT Regenerative Medicine Task Force
  • Member of the ISCT North American Legal and Regulatory Watchdog subcommittee
  • Co-founder of the ISCT Early Stage Professionals Committee
  • Co-editor of the ISCT e-newsletter, the Telegraft
  • Member of the ISCT Communications Committee
  • Non-voting member of the ISCT Global Executive Committee

Qualifications & Registrations

  • Certified Pharmaceutical cGMP Professional, American Society of Quality, 2014
  • Master of Science, Clinical Research, University of Pittsburgh School of Medicine, 2007
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As a Matter of FACT

The FACT accreditation program is a peer-review process.

Accreditation Success Story

The University of Utah Blood and Marrow Transplant Program began at the University Hospital in Salt Lake City in 1990. The program has been FACT accredited for 10 years, and offers suggestions for large programs considering FACT accreditation. Read more

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