Thursday 4th September, 2014
9:00am to 6:00pm
8.30 am to 9.00 am Registration & Breakfast
9 am to 10.30 am Overview of FDA Medical Device Regulation
10.30 to 11.00 am Tea break
11.00 am to 12.30 pmOverview of FDA Device Manufacturing Issues
12.30 pm to 1.30 pm Lunch break
1.30 pm to 3.00 pmOverview of FDA Device Post-Market Surveillance
3.00 pm to 3.30 pm Tea Break
3.30 pm to 5.00 pm Overview of Global Supply Chain Issues
5.00 pm to 5.30 pm Q & A
Founder, Biotech Consultant LLC
Dr. 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 Johns Hopkins University and the University of Sciences in Philadelphia.
Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products. Dr. Colonna�s consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.
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