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Training


Process Validation


Performing process validation on computers and software used in Manufacturing can be a daunting and time consuming task. This workshop can help your organization learn to perform cost-effective Process Validation on complex equipment that frequently includes embedded software. In this workshop, you will learn cost-effective techniques that can provide your organization with the skills needed to achieve compliance in the most cost- effective manner.


Topics covered in this workshop include:

  • Process Validation Overview

    • Regulations and Guidance Documents
    • Terms and Concepts

  • Validation Overview

    • Process Equipment
    • Quality System
    • Third Party Software
    • OTS Software
    • Home-grown Software

  • Process Validation

    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)

  • Summary and Action Plan








Tailoring

tailor

This workshop can be tailored to the specifics of your current Quality System. As a result, you can immediately identify areas of potential regulatory exposure. By applying the techniques presented in this workshop, you can minimize or eliminate any potential exposure and improve the effectiveness of your process validation activities.

Call for details...




For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com


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Copyright ©2008 Software Quality Consulting, Inc. All rights reserved.

Updated January 2008