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  • Using an IQ / OQ / PQ Approach to Validating Medical Device

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Friday - Oct 19, 2012 10:00 AM
  • End Time:
  • Thursday - Sep 19, 2013 11:15 AM
  • Location:
  • Online
  • This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.

    Why Should You Attend:
    Software Validation is a hot topic with the FDA because of the numerous medical device recalls related to faulty software.
    This webinar provides a method for performing thorough software validation using well established methods of Installation Qualification, Operational Qualification and Performance Qualification. These terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall.

    Areas Covered in the Seminar:
    Development of software test plans.
    How to apply IQ / OQ and PQ techniques to software?
    Risk based software testing.
    How does Software Validation relate to Design Validation?
    Typical software tests.
    What is the appropriate sample size for software testing?
    Software issue tracking.
    How to address open issues when releasing software.

    Who Will Benefit:
    This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include:
    Systems Engineers
    Software testers
    Test Engineers
    Quality System Auditors
    Engineering Managers and personnel
    Regulatory Affairs
    Software Vendors

    Instructor Profile:
    Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.
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