9/27, 140TF, Room 378
contact: Prof. Sunny Zhou, Department of Chemistry and Chemical Biology firstname.lastname@example.org
“How Retail Pharmacy Is Regulated”
Donna Horn, RPh, DPh
Director, Patient Safety-Community Pharmacy
3 to 5 pm, presentation and Q&A
“Introducing FDA’s New England District” (e.g., accomplishments & inspectional resources)
Capt. Mutahar Shamsi and Dr. Lisa Leveille
CAPT Shamsi is currently the District Director of FDA’s New England District (NWE-DO). He started with FDA as an Engineering Analyst at the Winchester Engineering & Analytical Center (WEAC) in 1985. He transferred to the District Office in 1990 where he has worked as an IT Specialist, Investigator, Device Pre-Approval Manager, Device Team Leader and Compliance Officer. CAPT Shamsi was a Supervisory Investigator from 2002 – 2006 responsible for the Boston MA and Providence RI Resident Posts. He was selected as the NWE-DO Director of Compliance Branch and served in that position until 2010. CAPT Shamsi holds a B.S. in Biomedical Engineering (1985) and a M.S. in Electrical Engineering (1989) from Boston University as well as a M.S. in Computer Science (1995) from the University of Massachusetts, Lowell.
Lisa started her career at FDA in March 2001 as a Premarket Reviewer in CDRH’s Office of Device Evaluation reviewing all major premarket application types including 510(k)s, PMAs, and IDEs. Lisa has experience in several device areas including anesthesiology and respiratory as well as cardiovascular devices. In her time at CDRH, she helped write several guidance documents, participated in international standards meetings, helped to foster the Total Product Life Cycle approach in the CDRH network, and worked closely with other Center offices including Office of Science and Biometrics and the Office of Compliance on post market safety signals. In April 2010, Lisa moved to New England for her current position as Supervisory Consumer Safety Officer. She supervises a group of medical device investigators who inspect medical device manufacturing facilities across New England. Lisa is also the Co-Device Program Monitor and helps to identify firms for inspection both for routine and for-cause bases. Lisa received her Biomedical Engineering degree from Hofstra University in 1999.