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Sharon O’Callaghan, MT(ASCP)

Sharon O’Callaghan, MT(ASCP)

Consumer Safety Officer

United States Food and Drug Administration

Sharon O’Callaghan is a Consumer Safety Officer with the Division of Inspections and Surveillance, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research.  Ms. O’Callaghan has a Bachelor of Science degree in Medical Technology from the University of Maryland at Baltimore. Prior to joining FDA, she worked at a community hospital as a bench tech and supervisor in all areas of the laboratory.  She joined the FDA in 1988 as a medical technologist. Ms. O’Callaghan has managed the Biological Product Deviation Reporting since 1990.  She was instrumental in developing the regulation on Biological Product Deviation Reporting (21 CFR 600.14 and & CFR 606.171), which was published September 7, 2001.  She also developed two guidance documents to accompany this rule.  Ms. O’Callaghan also developed the deviation reporting system for the Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) and was instrumental in developing the guidance for HCT/P deviation reporting (21 CFR 1271.350(a)). She has participated in many outreach efforts to the blood and plasma industry, the traditional biological product industry, as well as the HCT/P industry. 

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