Conference Program

Tuesday, September 23, 2008

201 Practical Process Validation Solutions to Industry Processes

Instructor: Brian Callahan, President, EEC & Associates

This session will discuss:

  • Evolution of Validation
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Process Validation
  • Statistical Tools and Techniques
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    A complete conference brochure PDF is available by clicking here

    ABOUT THE INSTRUCTOR

    Brian Callahan, President, EEC & Associates

    Brian Callahan is an independent consultant in the medical device regulatory field. He was formerly director of education for Quintiles Consulting and provided compliance training to clients worldwide. He has designed and delivered training modules that include IQ, OQ, PQ, process validation, preparing for an FDA investigation, validation master planning, SPC, executive management responsibility, reagent manufacturing, and test methods. Brian has more than 12 years of industry experience, nine within medical devices, IVDs, and drugs. He has validated facilities domestically and internationally to ensure cGMP compliance for the production of Class I, II, and III medical devices.

     

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