Excel Spreadsheet Validation for FDA 21 CFR Part 11 (PDF) by globalcompliancepane

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    Live Webinar         on
 
     Excel Spreadsheet Validation for FDA 21 CFR Part 11

                                                                                                                                    
     Course "Excel Spreadsheet Validation for FDA 21 CFR Part 11"
     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.


    Date & Time:
                                                                                           Instructor Profile:
     Thursday, June 14, 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
    Overview:
                                                                                           Touchstone Technologies Silicon
    This webinar will describe the regulatory and business requirements                    Valley, Inc. an FDA Compliance
    for Excel spreadsheets, using examples from FDA recommendations.                       company. She has almost 30 years
    It will then cover the design and installation of those Excel                          experience in the Lifesciences
    Spreadsheets, to ensure the integrity of the data, and will discuss                    industry and has applied for patents
                                                                                           aimed at speeding up Software
    how to ensure 21 CFR 11 compliance during the development,
                                                                                           Compliance. She is a member of the
    installation and maintenance of a spreadsheet application.
                                                                                           SQA CVIC (Society of Quality
                                                                                           Assurance Computer Validation
    Why should you attend:                                                                 Initiative Committee), DIA and RAPS
                                                                                           and teaches classes on 21 CFR 11,
    Spreadsheet Applications such as MS Excel are frequently used in 21                    Computer Systems Validation,
    CFR 11 compliant environments, but they were not specifically                          Compliance Strategy and Project
    designed for regulated environments and their development is not                       Management. More recently, Ms.
    optimized for 21 CFR 11 compliance. However, the FDA expects that                      Bazigos was selected to co-author
    spreadsheets be compliant and lack of compliance can result in a                       Computerized Systems In Clinical
    warning letter. Consequently, validation of Excel Spreadsheet                          Research / Current Data Quality and
                                                                                           Data Integrity Concepts with FDA,
    Applications is required as part of a 21 CFR 11 compliant
                                                                                           DIA and Academia. ...more
    environment.


    Areas Covered in the Session:                                                         Suggest a Topic       More Webinars

       l   Requirements for Excel Spreadsheets                                              Your Necessity is our Priority
       l   FDA Part 11 Validation Guidance
       l   Compliance Problems with Spreadsheets
       l   Design Specifications for 21 CFR 11 compliance
       l   How does the FDA Design and Use spreadsheets
       l   Documentation for Part 11                                                                         
       l   Future Trends in 21 CFR 11 compliance for Excel Spreadsheets


    Click here to register for this webinar


    Who Will Benefit:


       l   Quality Managers
       l   Quality Engineers
       l   Small business owners
       l   Internal and external auditors
       l   Management Reps
       l   FDA inspectors
       l   Consultants



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Best regards,
Event-coordinator
GlobalCompliancePanel



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