Deborah Griffin MSc, ASQ CPGP

Debe has over 25 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 an active member of the FACT Quality Committee in FACT. Deborah was formerly the Chair of the ISCT North America Legal and Regulatory Committee as well as Editor of the Telegraft. She 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