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


More Info

    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
                                                                                           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

    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

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
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

1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884

If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

To top