Project Management for Computer Systems Validation -Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                on
     Project Management for Computer Systems Validation

    Date & Time:                                                                                                                    

     Course "Project Management for Computer Systems Validation"
     has been pre-approved by RAPS as eligible for up to 1.5 credits
                                                                                                Register Now                         

     towards a participant's RAC recertification upon full completion.

                                                                                           Instructor Profile:
     Wednesday, August 29, 2012         10:00 AM PDT | 01:00 PM EDT

     Duration: 90 Minutes               Instructor: Angela Bazigos                                     Angela Bazigos
                                                                                                       CEO, Touchstone
     Location: Online                   Price : $245.00   (for one participant)
                                                                                                   Technologies Silicon Valley

                                                                                           Angela Bazigos is the CEO of
                                                                                           Touchstone Technologies Silicon
                                                                                           Valley, Inc. an FDA Compliance
    Per the CDRH, 20% of product recalls in the medical device industry                    company. She has almost 30 years
    are due to faulty software!!! Yet, these human, financial and                          experience in the Lifesciences
                                                                                           industry and has applied for patents
    reputation capital expensive issues, can be averted with
                                                                                           aimed at speeding up Software
    computerized systems validation and 21 CFR 11 compliance. The
                                                                                           Compliance. She is a member of the
    Project Manager for a Validated Computerized System, has to deliver                    SQA CVIC (Society of Quality
    on time and on budget, but with the added risk of having to meet                       Assurance Computer Validation
    regulatory compliance, often causing project overruns, regulatory                      Initiative Committee), DIA and RAPS
    findings and missed times to market.                                                   and teaches classes on 21 CFR 11,
                                                                                           Computer Systems Validation,
    This class, will explain the basic tenets of project management, the                   Compliance Strategy and Project
                                                                                           Management. More recently, Ms.
    basic tenets of 21 CFR 11 compliance for Computer Systems
                                                                                           Bazigos was selected to co-author
    Validation and will show how to marry the two, to deliver on time              
                                                                                           Computerized Systems In Clinical
    and on budget while meeting regulatory compliance requirements.                        Research / Current Data Quality and
                                                                                           Data Integrity Concepts with FDA,
                                                                                           DIA and Academia.
    Areas Covered in the Session:
                                                                                           Angela Bazigos has been accepted
       l   FDA Inspections - background                                                    into the prestigious ranks of Stanford
       l   Causes of Form 483 / Warning Letter                                             Who's Who as a result of her
       l   Some recent results of companies failing to respond                             remarkable work in the
                                                                                           biotechnology industry. Throughout
                                                                                           her brilliant professional career,
       l   Best Practices for Responding to 483
                                                                                           Angela has routinely exhibited the
       l   Best Practices for Responding to Warning Letter
                                                                                           passion, vision and dedication
       l   What to do if the responses fail                                                necessary to be successful in the
                                                                                           business world. ...more
    Click here to register for this webinar

    Who Will Benefit:                                                                     Suggest a Topic       More Webinars

                                                                                            Your Necessity is our Priority
       l   Project Managers
       l   IT Management
       l   Business Process Owners
       l   Quality Managers
       l   Quality Engineers
       l   GxP
       l   Consultants

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,

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
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