Biomedical software regulation

Page 1

Having trouble viewing this Message? View it Online

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

Register Now

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

Click here to register for this webinar

...more Suggest a Topic

More Webinars

Compliance4All www.compliance4all.com

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from Compliance4All Click Unsubscribe


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.