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FDAnews New Workshop, 2 Weeks to Register — Innovative Process Validation Strategies for Medical Devices, Aug. 26-27, 2014, Bethesda, MD
Date:8/14/2014

ments in QSR and how to understand them
  • The relationship between QSR and ISO 13485:2003
  • Using QSIT to help implementation
  • The issues raised by recent warning letters and how they can help guide the approach
  • The role of Installation Qualification (IQ) and the relationship with OSHA regulations
  • Understanding process capability and its role in defining an effective process
  • Understanding how Operational Qualification (OQ) determines process validation
  • The role of Performance Qualification (PQ)
  • Production issues for validated processes
  • Who Will Benefit:

    • Project managers involved in design and development
    • Design engineers
    • Quality engineers
    • Manufacturing engineers
    • Quality auditors
    • Production managers
    • Production supervisors
    • Scientists involved in device R&D and manufacturing
    • Training personnel
    • General/corporate counsel
    • Production engineers
    • Risk management specialists

    Meet the Instructor:
    Dan O’Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices and clinical labs. Dan is now President of Ombu Enterprises, LLC, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics, is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

    Conference Details:
    Innovative Process Validation Strategies for Medical Devices:
    Proving Your Processes and Documentation to the FDA
    **Presented by Ombu Enterprises and FDAnews**
    Aug. 26-27, 2014 – Bethesd
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