What to do if you get a FDA 483 Warning Letter by globalcompliancepane


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    Live Webinar           on
     What to do if you get a FDA 483 Warning Letter

    Date & Time:                                                                                                                     

     Thursday, March 29, 2012            10:00 AM PDT | 01:00 PM EDT
                                                                                                 Register Now                        
     Duration: 90 Minutes                Instructor: Angela Bazigos

     Location: Online                    Price : $245.00   (for one participant)

                                                                                            Instructor Profile:

                                                                                                       Angela Bazigos
    Audits by the FDA are perhaps the most intimidating of all events at                               CEO, Touchstone
    a regulated facility. Each year, the FDA conducts several thousand                             Technologies Silicon Valley
    audits, approximately half of which lead to findings that result in
    Form 483s.                                                                              Angela Bazigos is the CEO of
                                                                                            Touchstone Technologies Silicon
    Most Form 483 audits are amicably resolved, but a few lead to                           Valley, Inc. an FDA Compliance
    serious consequences for the audited parties, starting with Warning                     company. She has almost 30 years
                                                                                            experience in the Lifesciences
    Letters and ending with heavy fines and jail time for a few.
                                                                                            industry and has applied for patents
                                                                                            aimed at speeding up Software
    This webinar, will assist you in responding to a 483 or Warning                         Compliance. She is a member of the
    Letter so the consequences of the findings do not escalate beyond                       SQA CVIC (Society of Quality
    the current status.                                                                     Assurance Computer Validation
                                                                                            Initiative Committee), DIA and RAPS
                                                                                            and teaches classes on 21 CFR 11,
    Areas Covered in the Session:                                                           Computer Systems Validation,
                                                                                            Compliance Strategy and Project
       l   FDA Inspections - background                                                     Management. More recently, Ms.
                                                                                            Bazigos was selected to co-author
       l   Causes of Form 483 / Warning Letter
                                                                                            Computerized Systems In Clinical
       l   Some recent results of companies failing to respond
                                                                                            Research / Current Data Quality and
           appropriately                                                                    Data Integrity Concepts with FDA,
       l   Best Practices for Responding to 483                                             DIA and Academia. ...more
       l   Best Practices for Responding to Warning Letter
       l   What to do if the responses fail

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benefit from this program.

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

Best regards,

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