Federico Rodriguez BSMT, SBB (ASCP)

Federico has over 35 years of experience in immunohematology and cellular therapy fields and has held numerous different positions during his career: Medical Technologist, Sales Specialist, Laboratory Supervisor, Education Coordinator, Laboratory Manager, Technical Director, Adjunct Faculty, FACT Consultant, and most recently as Client Services Manager for FACT Consulting. He has provided guidance to laboratories and institutions in all aspects of manufacturing, regulatory requirements and compliance, process design, process improvement and quality management systems worldwide, including the United States, Latin America, and the Middle East. Federico has been a FACT inspector since 2005 and has performed multiple inspections nationally and internationally. In addition, he was part of a team of inspectors for a pilot program to perform inspections in Spanish. He is an active member of the AABB, ASFA, ASTCT, ISCT, and SCABB; he has participated and continues to be a member of several Committees within these organizations.

Areas of Expertise

Quality Management Systems; FACT, NetCord, CAP, AABB, cGTP, GLP and cGMP compliance; process and facility design, and laboratory workflow, LEAN; document control and writing including policies, procedures, processes, gap analysis, project management, abstracts, posters, scientific publications, and multiple clinical trials; staff training, coaching and mentoring, marketing, new BMT and IEC program development (for collections and processing laboratory); onboarding IEC (FDA approved) therapies, equipment qualification and validations including IQ, OQ and PQ.

Scope of Experience

13 years of bench tech laboratory experience.
20 years of laboratory management experience.
Teaching, coaching, and mentoring roles throughout professional career.
Participating as speaker, chair / moderator, and panel of experts (round tables) in national meetings and international congresses.

Market Sector Focus

Hematopoietic stem cell collection and processing (bone marrow, apheresis and cord blood products).
Bone marrow collection and processing for cardiac indications, phase III clinical trials, onboarding novel cellular therapies (IEC).
New BMT and IEC program development.

Relevant Assignments

Performed more than 20 FACT and FACT-NetCord inspections of cell collection facilities, processing laboratories, and cord blood banks national and international.
Performed more than 25 FACT Consulting engagements including on-site compliance assessment and new BMT and IEC program development.
Former Co-editor of the ISCT e-newsletter, the Telegraft.
Former Member, Vice-Chair and Chair of the ISCT Laboratory Practices Committee.
Former Member of the Board of Directors for the Suzanne Ledin Memorial Foundation.
Former Chair of the Spanish Language Subsection of the AABB.
Former Member of the Board of Directors of the AABB.