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    AUDITS BY THE FDA ARE PERHAPS THE MOST INTIMIDATIN 2013 - The Hitchhiker's guide to 483s and Warning Letters - Webinar By GlobalCompliancePanel

    View: 313

    Website http://bit.ly/10zLRX0 | Want to Edit it Edit Freely

    Category Webinar, Health, Pharma, Medical Device, FDA, Clinical

    Deadline: May 30, 2013 | Date: May 30, 2013

    Venue/Country: California, U.S.A

    Updated: 2013-05-17 14:10:28 (GMT+9)

    Call For Papers - CFP

    Overview: Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. A fun way to present this serious topic!! 483’s and their more serious counterparts, Warning Letters, are Citations issued by the FDA as a result of issues uncovered during an Inspection.

    Areas Covered In the Session: This presentation will use humor to describe:

    Why the FDA issues such citations

    What is a 483 and what does it look like

    What is a Warning letter and what does it look like

    What is the difference between a 483 and a Warning Letter

    What they mean for your company

    How to respond to 483s and Warning Letters to avoid escalation by the FDA

    How to prevent future issues during inspection and avoid future issuances of 483s and Warning Letters

    Who will benefit:

    CEO

    Regulatory VP

    Quality VPs

    IT VPs

    Regulatory Affairs Professionals

    Quality Managers

    Quality Engineers

    Small Business Owners

    GxP

    Consultants

    Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

    NetZealous LLC,

    DBA GlobalCompliancePanel

    161 Mission Falls Lane,

    Suite 216, Fremont, CA 94539, USA

    USA Phone:800-447-9407

    Fax: 302-288-6884

    webinarsatglobalcompliancepanel.com

    http://www.globalcompliancepanel.com

    Event Link - http://bit.ly/10zLRX0


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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