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    Webinar on FDA Regulation of Medical Device Software

    View: 439

    Website http://bit.ly/1MCN2jf | Want to Edit it Edit Freely

    Category Medical Device Software; Online Compliance training; Compliance program online

    Deadline: November 29, 2015 | Date: November 30, 2015

    Venue/Country: Fremont, U.S.A

    Updated: 2015-09-29 21:16:13 (GMT+9)

    Call For Papers - CFP

    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).

    Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. FDA did not have to create a software regulatory policy until the late 1980's when companies began incorporating primitive software programs in medical devices. Software can be a device by itself (i.e., stand-alone) or it can be incorporated into another device as a component, part or accessory. Under the current policy, FDA distinguishes between stand-alone software and software that is a component, part or accessory to a device.

    Why should you Attend:

    To gain a fundamental understanding of FDA regulation of medical device software.

    Areas Covered in the Session:

    Definition of medical device software

    FDA's medical device software regulatory scheme

    Software validation

    Level of concern

    Who Will Benefit:

    Compliance Manager

    Validation Manager

    Regulatory Manager

    QC Managers

    QA Managers

    Speaker Profile:

    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.

    Contact Detail:

    NetZealous - Compliance4All,

    161 Mission Falls Lane, Suite 216,

    Fremont, CA 94539, USA.

    Phone: +1-800-447-9407

    Email: supportatcompliance4All.com

    http://www.compliance4all.com/

    Event Link : http://bit.ly/1MCN2jf


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.