Validation and Use of Excel� Spreadsheets in Regulated Environments - Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                 on

     Validation and Use of Excel® Spreadsheets in Regulated

    Date & Time:                                                                                                                   

     Course "Validation and Use of Excel® Spreadsheets in
     Regulated Environments" has been pre-approved by RAPS as
                                                                                                Register Now                       

     eligible for up to 1.25 credits towards a participant's RAC
     recertification upon full completion.

                                                                                           Instructor Profile:

     Tuesday, August 28, 2012           10:00 AM PDT | 01:00 PM EDT
                                                                                                      Dr. Ludwig Huber
     Duration: 75 Minutes               Instructor: Dr. Ludwig Huber                               Chief Advisor - Global FDA
                                                                                                      compliance, Agilent
     Location: Online                   Price : $245.00   (for one participant)                           Technologies

                                                                                           Ludwig Huber, Ph.D., is Director of
    Overview:                                                                              Labcompliance and Chief Advisor for
    Excel® Applications are widely used in laboratories, offices and                       global FDA compliance at Agilent
    manufacturing e.g., for data capture, data manipulation and report                     Technologies. He is the editor of
    generation. Regulations such as HIPAA, Sarbanes Oxley Act and                          Labcompliance, the global on-line
                                                                                           resource for validation and
    FDA's GxP and 21 CFR Part 11 require users of software and
                                                                                           compliance issues for laboratories.
    computer systems to demonstrate and document data accuracy,
                                                                                           He is the author of the books
    integrity and confidentiality.                                                         "Validation and Qualification in
                                                                                           Analytical Laboratories, and
    Out-of-the box Excel® has not been designed for regulated                              "Validation of Computerized
    environments. However, with a good knowledge of Excel®                                 Analytical and Networked Systems",
    capabilities combined with good procedures and practices on how to                     Informa Healthcare. ...more
    validate and use Excel® requirements can be met. For example, the
    FDA is widely using Excel® and complies with its own regulations.
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    Areas Covered in the Session:
                                                                                            Your Necessity is our Priority

       l   Regulatory requirements for spreadsheets; FDA Part 11, GxP,
           HIPAA, Sarbanes-Oxley.
       l   Recommendations from the new GAMP®5 and EU Annex 11
       l   How to design spreadsheets for compliance.                                                        
       l   How to ensure and validate spreadsheet integrity.
       l   When, what and how much to test?
       l   Validation of standard/native Excel functions?
       l   How to apply risk based validation to spreadsheet applications
       l   Validation of 'ad hoc' spreadsheet applications.
       l   How to document planning, specifications, installation, testing
           and changes
       l   Examples from manufacturing, laboratories and offices

    Click here to register for this webinar

    Who Will Benefit:

       l   Everybody developing and using Excel Worksheets for
           regulated environments
       l   QA managers and personnel
       l   QC managers and personnel
       l   IT managers and personnel
       l   Analysts and lab managers
       l   Validation groups
       l   Validation professionals
       l   Training departments
       l   Documentation department
       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
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
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