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Live Webinar Biomedical Software Regulation Date: Thu, December 11, 2014
Time: 10:00 AM PST | 01:00 PM EST
Instructor:Thomas E. Colonna
Location: Online
Duration: 60 Minutes
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Overview: The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
Areas covered in the session: Definition of biomedical software FDA's biomedical software regulatory scheme Software validation Level of concern
Who Will Benefit: CEOs VPs Compliance officers Clinical affairs Regulatory affairs Quality assurance R&D CROs Consultants Contractors/subcontractors
About Speaker Thomas E. Colonna Founder, Biotech Consultant LLC Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at
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