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.
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.