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Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations

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    Live Webinar          on

      Avoiding FDA 483 Observations by Identifying the Root Cause of
      Deviations

                                                                                                                                    
     Course "Avoiding FDA 483 Observations by Identifying the Root
     Cause of Deviations" has been pre-approved by RAPS as
                                                                                               Register Now                         
     eligible for up to 1.5 credits towards a participant's RAC
     recertification upon full completion.


    Date & Time:                                                                         Instructor Profile:

     Tuesday, June 19, 2012               10:00 AM PDT | 01:00 PM EDT
                                                                                                      John G. Lanese
     Duration: 90 Minutes                 Instructor: John G. Lanese                              President, Lanese Group,
                                                                                                             Inc.
     Location: Online                     Price : $245.00   (for one participant)

                                                                                         John G. (Jerry) Lanese, Ph.D.
                                                                                         CMC is the president of The Lanese
     Overview:                                                                           Group, Inc, an independent
    Recent Consent Decrees have included requirements that the firm                      consulting service provider that
    develop and implement systems that result in timely and complete                     specializes in Quality Systems and
    investigations of deviations and corrective and preventive actions                   Laboratory Controls. Jerry has
                                                                                         taught at the college level and
    that address the root cause of deviations.
                                                                                         worked in various Quality Control
                                                                                         and Quality Assurance roles in small
    FDA 483 and Warning letter observations identify inadequate                          and large pharmaceutical firms. For
    investigations and follow-up. This webinar addresses adequate                        the last 15 years he has consulted in
    investigation of deviations. Participants will obtain a greater insight              a wide range of projects from
    into effective investigations and ways to identify the root cause and                consent decree remedial actions with
    prevent a similar deviation in the future.                                           large pharmaceutical firms to
                                                                                         systems development for a small
                                                                                         component manufacturer. He has
    The investigation of deviations is clearly a US FDA expectation. The
                                                                                         lectured throughout the world to
    international regulatory expectation for a structured approach to
                                                                                         clients and for major seminar
    investigations that lead to corrective actions and preventive actions                providers. He was voted the best
    is clearly stated in ICH Q10, Pharmaceutical Quality System, and                     presenter of the year in 2001 by the
    supported in the FDA Guidance to the Industry, Quality System                        Institute of Validation Technology. In
    Approach to Pharmaceutical CGMP Regulations. This course will                        2008 he received the Kenneth
    include a discussion of the Deviation System, what should be                         Chapman Industry Recognition
    investigated and the level of investigation. Several tools that will                 Award. ...more

    lead to the identification of the root cause will be discussed. These
    include: process mapping, brainstorming, cause analysis, cause and
    effect and the 5 Whys. The investigation system will be integrated                  Suggest a Topic       More Webinars
    with the CAPA and Change Control Systems.
                                                                                          Your Necessity is our Priority

     Why should you attend:
    Recent Consent Decrees have included requirements that the firm
    develop and implement systems that result in timely and complete
    investigations of deviations and corrective and preventive actions                                     
    that address the root cause of deviations. FDA 483 and Warning         
    letter observations identify inadequate investigations and follow-up.
    This webinar addresses adequate investigation of
    deviations. Participants will obtain a greater insight into effective
    investigations and ways to identify the root cause and prevent a
    similar deviation in the future.


     Areas Covered in the Session:


        l   What should be investigated - Complaints, audit observations,
            deviations, discrepancies, calibration out-of-tolerances
        l   FDA expectations for investigations
        l   The investigation-problem resolution process - understand the
            problem, identify possible causes, data collection, data
            analysis, root cause identification, root cause elimination,
            solution implementation, verify success
        l   Tools for understanding the process - mapping, critical
            incident, performance matrix
        l   Tools for understanding the possible causes - brainstorming,
            is/is not, nominal group
        l   Tools for narrowing the investigation to the most probable
            cause - data collection, data analysis
        l   Determining the root cause - cause and effect, Fault tree, 5
            Whys.
     l   Corrective action
     l   Preventive Action
     l   Verification


 Click here to register for this webinar


  Who Will Benefit:
 The following individuals and disciplines will benefit from this
 webinar:


     l   QA document reviewers
     l   QA personnel responsible for reviewing investigations reports
     l   QA personnel responsible for the deviation and investigations
         systems
     l   Quality and Operations personnel responsible for
         investigations
     l   Personnel from all units responsible for initiating investigations



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



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DOCUMENT INFO
Description: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations.