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Computer System Validation Step by Step (PDF)

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    Live Webinar         on
 
     Computer System Validation: Step-by-Step

                                                                                                                                   
     Course "Computer System Validation: Step-by-Step" has been
     pre-approved by RAPS as eligible for up to 1.25 credits towards
                                                                                              Register Now                         
     a participant's RAC recertification upon full completion.


    Date & Time:
                                                                                        Instructor Profile:
     Thursday, May 31, 2012              10:00 AM PDT | 01:00 PM EDT

     Duration: 75 Minutes                Instructor: David Nettleton
                                                                                                    David Nettleton
                                                                                                FDA Compliance Specialist,
     Location: Online                    Price : $245.00   (for one participant)


                                                                                        David Nettleton, is an FDA
    Overview:                                                                           Compliance Specialist for 21 CFR
                                                                                        Part 11, HIPAA, and Computer
    This webinar details all of the templates used to create validation
                                                                                        System Validation. His latest book is
    documentation, usually saving two-thirds of the time and costs. The
                                                                                        "Risk Based Software Validation -
    10-step risk-based approach to COTS software validation minimized                   Ten easy Steps" that relates to the
    documentation and ensures efficient implementation of new and                       development, purchase, installation,
    upgraded computer systems. This experience will prepare you to                      operation and maintenance of
    perform a validation project.                                                       computerized systems used in
                                                                                        regulated applications. He specializes
                                                                                        in performing gap analysis,
    Areas Covered in the Session:                                                       remediation plans, SOP
                                                                                        development, vendor audits,
                                                                                        training, and project management.
       l   Learn which documents the FDA expects to audit.
                                                                                        He has completed more than 185
       l   How to use the risk-based validation approach to lower costs.  
                                                                                        mission critical software validation
       l   How to link requirements, specifications, risk management,                   projects....more
           and testing.
       l   Document a computer system validation project using easy to
           understand fill-in-the-blank templates.
                                                                                       Suggest a Topic       More Webinars
       l   Based on: "Risk-Based Software Validation – Ten Easy
           Steps" (Davis Horwood International and PDA - www.pda.org,
                                                                                         Your Necessity is our Priority
           2006).
       l   Step-by-step instructions for performing and documenting a
           risk assessment, and how to use the results to reduce
           validation documentation.
       l   Reduce testing by writing test cases that trace to elements of
                                                                                                          
           risk management.


    Click here to register for this webinar


    Who Will Benefit:


       l   IT
       l   QA
       l   QC
       l   Laboratory staff
       l   Managers
       l   GMP, GCP, GLP professionals



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: This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.