Risk analysis

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					Live Webinar on : Risk analysis for software validation-step by step instructions
Wednesday, March 21, 2012 duration : 01:00 to 02:15 PM EST


                                       This webinar teaches how to perform risk assessment in
                                       order to reduce time for software testing. As part of the
Get 15 % Discount as an early bird     10-step risk-based approach to computer system
registration. Use Promo Key :          validation, the hazard analysis technique uses fill-in-the-
 CGO15                                 blank templates. Ensure compliance with QA, FDA, and
                                       clients. Learn real life examples that make application of
                                       the technique understandable in the context of any
Who will benefit                       validation project. As part of the workshop, perform
                                       your own hazard analysis so you can apply what you
                                       learn to what you do.
      IT
      QA
      QC
      Laboratory staff                It is recommended to take the COTS Software
      Managers                        Validation webinar as a prerequisit.
      GMP, GCP, GLP
       professionals                   .

                                       Learning Objectives:

                                              How to use the risk-based approach to reduce
                                               validation time and lower costs.
                                              Avoid 483s and Warning Letters.
                                              Step-by-step instructions for performing and
                                               documenting a hazard analysis.
                                              Interactive real life examples.
                                              How to document the risk assessment using a
                                              Reduce testing by writing test cases that trace to
                                               elements of risk management.
purchase formats                             Perform your own hazard analysis during the
    $189 One Dial In - One

     $249 One Dial In - Unlimited
attendance (To be arranged in a
Conference room/Meeting room.
Note : Only One Dial In Allowed)

    $289 On Demand (Recording         About Speaker:
available within 48 hrs after the
                                      Computer System Validation’s principal, David
completion of the webinar)
                                      Nettleton is an industry leader, author, and teacher for
                                      21 CFR Part 11, Annex 11, HIPAA, software validation,
                                      and computer system validation. He is involved with
    $349 Get Training CD              the development, purchase, installation, operation and
                                      maintenance of computerized systems used in FDA
                                      compliant applications. He has completed more than
                                      206 mission critical laboratory, clinical, and
                                      manufacturing software implementation projects. His
    More Trainings                    latest book is “Risk Based Software Validation -
                                      Ten easy Steps” (Davis Horwood International and
                                      PDA - www.pda.org, 2006) which provides fill-in-the-
                                      blank templates for completing a COTS software
                                      validation project.

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