Michael F. Breard MS, MT(ASCP)SBB, CQA(ASQ), PMP(PMI)
Division Director, Consulting Services
Michael is currently Division Director for AABB Consulting Services. Michael obtained his BS in Medical Technology from the University of North Carolina, Chapel Hill, received his Medical Technology Training at Duke University and his MS in Medical Technology from California State University. He has over 40 years experience in Blood Banking including transfusion service, donor center, commercial manufacturing (reagent, kit, instrument, software), project management and consulting. Experience includes assisting companies/clients with ISO certification, AABB Accreditation, FDA Inspection preparation, FDA 483 and Warning Letter Response/Compliance, cGMP and cGTP Training and Compliance, and Document Development/Training (SOPs, Processes, Policies, Quality Manuals, etc.). He is an active member of the AABB, ISBT, Project Management Institute, a Board Member and Director of Scholarships for the Suzanne Ledin Memorial Foundation and a Senior Member of the American Society for Quality, ISO 15189 Trained, Past Secretary of the TOPS/ASQ Section, Past VP of Communications for the Tucson PMI Chapter, VP of Finance for the Tucson PMI Chapter and Co-Chair of the ISBT Traceability Task Force.
Mary Kay Belota, MA, MT(ASCP)SBB
Mary Kay Belota, Consultant, brings over 25 years experience in cellular therapy, blood center operations, and transfusion medicine to AABB's Consulting Services Division. With such diverse experience, she is well-versed in accreditation and licensure requirements, to include FDA's cGMP and cGTP. Building organizational capacity, Mary Kay integrates standards and regulations with workplace protocols to achieve patient-centered, quality-driven operations. Prior to joining AABB, Mary Kay was the technical supervisor with the St. Louis Cord Blood Bank in St. Louis, MO, serving as the manufacturing subject matter expert during their successful application for FDA licensure. As the laboratory director of the GMP Facility at Washington University in St. Louis, Mary Kay focused on the development of quality systems for this translational research program. She gained Director-level experience in blood center operations with the American Red Cross Missouri-Illinois Region, responsible for collections, manufacturing, donor testing and blood product inventory management. Mary Kay managed the transfusion service at St. Louis University Hospital, a tertiary care teaching facility. Mary Kay received her Bachelor of Science degree in Medical Technology from West Virginia University and is certified as a Specialist in Blood Banking by the American Society for Clinical Pathology. She graduated from Washington University in St. Louis with a Master of Arts in Human Resources Management.
June A. Fried, CLS, MT(ASCP)BB, CQA(ASQ)
June Fried, AABB Consultant, has well over 20 years of experience in all areas of transfusion medicine and cellular therapies. She earned her BS in Medical Technology at the Medical University of South Carolina. She received her Medical Technology training at the MUSC Medical Center, located in Charleston, SC, and her BB(ASCP) certification after years of on-the-job training in facilities around the country. Having held both technical and management positions, June possesses a broad range of knowledge and skills essential to the successful operation of hospital based Transfusion Services, Blood & Marrow Transplant Programs, and university based Translational Research Facilities. In her most recent position as Director, Regulatory Affairs & Quality Assurance for MUSC's Center for Cellular Therapy, June acquired in-depth knowledge and experience in novel cell processing techniques such as those used in Pancreatic Islet isolations, umbilical cord & bone marrow derived Mesenchymal Stem Cell products, chemically modified Dendritic Cell cancer vaccines, and genetically modified autologous T-Cell products. Additional skills include validation of research/clinical protocols, application of quality principles to all aspects of translational research, implementation of quality plans specific to the needs of research facilities, preparation and submission of IND's, and coordination of FDA approved clinical trials. June's unique level of expertise has made her particularly successful in acquiring initial CT Facility accreditation, as well as implementing and maintaining regulatory compliance.
Elaine Viggiano, MBA, MT(ASCP)SBB, CQA(ASQ)
Elaine obtained her Bachelor of Science degree in Medical Technology from Rutgers University in New Jersey. She subsequently went on to obtain her SBB after studying in Boston, Massachusetts. She also has earned her MBA from the University of LaVerne in California. Elaine is certified as a Quality Auditor through the American Society for Quality. Her extensive experience includes Reference Laboratory studies, tertiary care Transfusion Medicine operations, and central testing operations for the plasma industry. Most recently, Elaine has held executive level positions as the head of Quality Assurance and Regulatory Affairs for the volunteer blood segment. Elaine has also devoted several years to AABB as an Assessor, as well as serving on various AABB committees, most recently as the Chair of the Quality/Education sub-track of the Annual Meeting Education Program Unit. Elaine offers a solid skill and experience base in Quality/Regulatory and Laboratory operations activities in the Donor Center/Transfusion Service/Plasma industries.