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Validate your own Excel Spreadsheet Application

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    2-day In-person Seminar on
 
     Validate your own Excel Spreadsheet Application

                                                                                                                                    
     Course "Validate your own Excel Spreadsheet Application" has
     been pre-approved by RAPS as eligible for up to 12 credits
                                                                                               Register Now                         
     towards a participant's RAC recertification upon full completion.


    Date & Time:
                                                                                         Instructor Profile:
     July 26th and July 27th 2012         8 AM to 5 PM EDT

     Duration: 2 Days                     Instructor: David Nettleton
                                                                                                     David Nettleton
                                                                                                 FDA Compliance Specialist
                                          Price : $1495.00   (for one
     Location: San Francisco
                                          participant)

                                                                                         David Nettleton, is an FDA
                                                                                         Compliance Specialist for 21 CFR
    Overview:                                                                            Part 11, HIPAA, and Computer
                                                                                         System Validation. His latest book is
    In this two day seminar you will learn how to configure your Excel
                                                                                         "Risk Based Software Validation -
    application with the features required for 21 CFR Part 11 compliance
                                                                                         Ten easy Steps" that relates to the
    helping you to avoid 483s. Using the risk based computer system                      development, purchase, installation,
    validation approach you will validate your own Excel application. Use                operation and maintenance of
    of the validation templates typically saves two thirds of the validation             computerized systems used in
    time and costs.                                                                      regulated applications. He specializes
                                                                                         in performing gap analysis,
    This seminar will improve your Excel skills and create a set of                      remediation plans, SOP
                                                                                         development, vendor audits,
    validation documents that you can use for subsequent Excel
                                                                                         training, and project management.
    application validation projects.
                                                                                         He has completed more than 185
                                                                                         mission critical software validation
    Course Outline:                                                                      projects. ...more



    Day 1:
                                                                                        Suggest a Topic       More Webinars
       l   Introductions
                                                                                          Your Necessity is our Priority
       l   Regulations for Electronic Records
       l   21 CFR Part 11 - Electronic Records & Signatures
       l   The Risk-Based Validation Approach
       l   Excel Applications - part 1
               ¡   Create a User Requirements document for your
                                                                                                           
                   application
               ¡   Create a Project Plan document for your application
               ¡   Create a Functional Specifications document for your
                   application                                                   


    Day 2:


       l   How to Conduct a Hazard Analysis/Risk Assessment
       l   Excel Applications - part 2
               ¡   Create a Hazard Analysis document for your application
               ¡   Create a Testing Protocol document for your application


       l   Main Concepts to Remember
       l   Q&A


    Areas Covered in the Session:


       l   Develop spreadsheet applications that are GxP compliant.
       l   Avoid 483s and warning letters.
       l   What does and does not need to be validated.
       l   Learn how to use Excel’s built in 21 CFR Part 11 features.
       l   Apply features required for GxP environments without
           programming macros.
       l   Validate your application with minimal documentation.
       l   Understand how to use risk assessment to reduce testing and
           improve productivity.
       l   Participate in the workshop as we configure Excel for audit
           trails, security features, data verification, and multiple
           concurrent users.
       l   Learn how to specify and test your application.
 Click here to register for this seminar


  Who Will Benefit:


     l   All Excel users
     l   IT
     l   QA, QC
     l   Laboratory staff
     l   Managers, Executives



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: In this two day seminar you will learn how to configure your Excel application with the features required for 21 CFR Part 11 compliance helping you to avoid 483s. Using the risk based computer system validation approach you will validate your own Excel application. Use of the validation templates typically saves two thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application validation projects.