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    Webinar on A second look at 510(k) changes

    View: 323

    Website http://bit.ly/1haBf0O | Want to Edit it Edit Freely

    Category fda 510 k process for medical devices;fda medical device 510 k;Upcoming Changes to the Process;FDA Regulatory Affairs

    Deadline: October 14, 2015 | Date: October 15, 2015

    Venue/Country: Fremont, U.S.A

    Updated: 2015-09-22 14:45:11 (GMT+9)

    Call For Papers - CFP

    Overview:

    The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

    Therefore, it is up to the sponsor/manufacturer to determine whether this change will be significant or not. The decision has to be made by the manufacturer, subject to review by the FDA inspector. This talk will provide quality and regulatory personnel the means to help to the company make the right decision and document it fully, before the change goes through.

    Why should you Attend:

    Failure to file a 510(k) for a change to a product which has already been cleared under 510(k) is one of the more frequent complaints in 483's and in warning letters. The result of this finding is the requirement to file a 510(k) for a product that is on the market, and usually, to file a 510(k) and have the change cleared before the product can be marketed with the change. In general, FDA will not insist on recalling product with the change already in the market unless they decide there is a safety issue, but even so, this means disruption of the manufacturing (already producing the changed product) and marketing for the product. The best approach is to understand what FDA means by a "significant change" and document completely the reasons why you believe the change does not warrant a filing.

    Areas Covered in the Session:

    Background: the regulation

    Guidance and FDA expectations

    Concrete examples

    Analysis (consecutive changes)and checklist

    Documentation

    Who Will Benefit:

    QA and RA specialists

    QA and RA managers

    Speaker Profile:

    Anna Longwell is currently principal attorney of the Palo Alto Law firm, Longwell and Associates, which specializes in Food and Drug law. The firm has expertise in US FDA expectations, regulation and law, affecting the development and ultimate marketing of new medical products, drugs, devices and biologics. They have served the regulatory needs of large (>$2 billion/year) divisions of Fortune 500 companies, and small (4 person) biotech start-ups. Prior to establishing the firm, Ms. Longwell was VP of Regulatory affairs for Becton Dickinson, Medical a > $2 billion/annum unit of BD engaged in global manufacture and sale of medical devices, consumer products and OTC drugs. In that context, she participated as regulatory expert in many pre-acquisition due diligence teams.

    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/1haBf0O


    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.