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Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel

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Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                  


 
    Live Webinar
    Preparing for FDA Inspections in a Changing Regulatory Environment
     Date:         Wednesday, September 22, 2010

     Time:         10:00 AM PDT | 01:00 PM EDT
                                                                                              Register Now
     Duration: 60 Minutes

     Price:        $245.00
    Overview:
    The key to effective management of regulatory inspections is
                                                                                       Instructor Profile:
    effective preparation. Being well organized and confident during the
    inspection means that your firm gives it's best possible performance
                                                                                                Nancy Duarte-Lonnroth
    which in turn gives the regulatory inspector the clear message that
                                                                                                  Director, Quality and
    you know your business thoroughly. In this webinar, you will learn
                                                                                               Regulatory Affairs, Celestica
    the key principles of the preparation of staff that will be expected to
    face the inspector(s).
                                                                                       Nancy is the Director of Quality &
                                                                                       Regulatory Affairs, Healthcare
    This webinar was developed to help participants to determine what                  responsible for global coordination of
    actions are needed to build a robust system for handling regulatory                Celestica’s Healthcare Quality,
    inspections.                                                                       Regulatory and FDA compliance.
                                                                                       Nancy is Quality and Regulatory
    Areas Covered in the Session:                                                      expert with fifteen years experience
                                                                                       in regulatory affairs, quality
    l   Current trends                                                                 systems, compliance, clinical quality,
    l   Staff Training and Preparation                                                 validation, auditing, quality control,
    l   Key steps to becoming inspection ready                                         data management systems, post
                                                                                 
    l   Facing the inspector - Competent, Confident, Credible,                         market surveillance, supplier
        Knowledgeable                                                                  management and regulatory
    l   Managing the inspection process                                                compliance in the areas of
                                                                                       bio/pharmaceuticals, medical
        ¡   Use of high level presentations                                            devices and combination products.
        ¡   Likely targets                                                             Nancy has contributed to the success
        ¡   Know and respect the inspector's techniques                                of both venture and public
        ¡   Behaviors to encourage                                                     companies, establishing a track
        ¡   Behaviors to avoid                                                         record of successfully achieving
                                                                                       timely global regulatory approvals,
                                                                                       initiating and effectively managing
    Click here to register for this webinar
                                                                                       preclinical and clinical investigations
                                                                                       and developing and maintaining
    Who Will Benefit:                                                                  effective and compliant quality
    l   Regulatory Unit                                                                systems in various healthcare
                                                                                       sectors. ...more
    l   QA Unit
    l   Manufacturing
    l   Validation
    l   Consultants                                                                 Suggest a Topic        More Webinars
    l   Quality system auditors
                                                                                        Your Necessity is our Priority




    It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
    benefit from this program.

    For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

    Best regards,
    Event-coordinator
    GlobalCompliancePanel



    About GlobalCompliancePanel
    GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
    compliance training by creating a single window of learning opportunities for compliance professionals & providing a
    forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
    commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
    sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
    giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
    GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
    and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
    event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
    professionals.


    GlobalCompliancePanel
    www.globalcompliancepanel.com
    1000 N West Street Suite,
    1200 Wilmington DE 19801

    Phone: 800-447-9407 or
    Fax your PO to: 302-288-6884
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DOCUMENT INFO
Description: The key to effective management of regulatory inspections is effective preparation. Being well organized and confident during the inspection means that your firm gives it's best possible performance which in turn gives the regulatory inspector the clear message that you know your business thoroughly. In this webinar, you will learn the key principles of the preparation of staff that will be expected to face the inspector(s). This webinar was developed to help participants to determine what actions are needed to build a robust system for handling regulatory inspections.