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Charma A. Konnor, R.PH., RAC, Executive
Director/Consultant, Devices and Drugs, has had over 25 years
of experience with the Food and Drug Administration (FDA)
directing regulatory and compliance activities. Ms. Konnor
is a Fellow of the Regulatory Affairs Professionals Society
(RAPS). She received numerous FDA awards for her leadership
and improvements in pharmaceutical and device programs. While
in the Center for Devices and Radiological Health (CDRH),
she was Director of the Division of Bioresearch Monitoring
(BIMO), where she initiated significant improvements in bioresearch
monitoring of preclinical and clinical device trials (GCPs),
Application Integrity Policy (AIP) implementation, and enforcement
of the promotion of investigational devices.
Prior to her tenure with CDRH, Ms. Konnor was, for an extended
period of time, Acting Director of the Office of Compliance
in the Center for Drug Evaluation and Research (CDER). In
her position at CDER, she had senior executive responsibility
for programs and enforcement that included drug product quality
and manufacturing, labeling, marketing and distribution, surveillance,
registration and listing. She also was Director of the Division
of Prescription Drug Compliance and acting Director of FDA's
Florida District Office. In earlier years, she was an OTC
drug reviewer, health policy staff deputy in the Commissioner's
Office, and director of the FDA-USP compendial standards liaison
staff. She also practiced clinical pharmacy.
Ms. Konnor is certified in Regulatory Affairs and has a Pharmacy
degree from Wayne State University, where she graduated at
the top of her Pharmacy class. She has active Pharmacist licenses
in Virginia and Michigan. She serves on the editorial boards
for Guide to Good Clinical Practice and BioResearch
Compliance Report.
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