Medical Device Purchasing Controls - Webinar CD/Transcript

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Medical Device Purchasing Controls: Building Compliant Systems

FDA investigators are keeping a sharp eye on your supplier management program.  How can you remain in compliance?

Industry expert Dan helps you understand expectations using the regulations, their explanation in the QSR preamble, the GHTF guidance, and warning letters that illustrate the issues.

After listening to this 90-minute session you will be able to:

  • Describe the elements of supplier evaluation and selection
  • Develop “purchasing data” to define the component, service, and supplier requirements
  • Maintain supplier records to demonstrate the systems effectiveness
  • Establish procedures to accept or reject incoming product or services
  • Explain the additional requirements in ISO 13485:2016

BONUS MATERIALS: Attendees will receive a QSR checklist for supplier selection and control and a comparative analysis in QSR, ISO 13485:2003 and ISO 13485:2016 requirements.

Order today and begin creating an integrated, efficient and compliant supplier management system.

  • Purchasing managers
  • Purchasing agents
  • Quality managers
  • Supplier quality engineers
  • Inspection managers
  • Manufacturing engineers
  • Management Representatives

Dan O’Leary is the President of Ombu Enterprises, LLC., a company offering training and execution in Operational Excellence, focused on analytic skills; and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including: aviation, defense, medical devices, and clinical labs. 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.