Supplier Quality Agreements for Medical Devices

Instructor: Dan OLeary 
Product ID: 702848
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Nov-2013

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

This training on medical device supplier management will explain the elements of a supplier quality agreement and discuss practical steps for implementation.

Why Should You Attend:

Effective supplier management can help prevent problems and reduce their impact should they occur. With the increased emphasis on supplier management, you can expect strong coverage of this area during an FDA Inspection. The FDA's Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One common approach uses a supplier quality agreement.

This 90-minute training will help you understand the FDA QSR requirements, good business practices, and the role of a supplier quality agreement. This webinar will help you set up an effective and FDA compliant supplier management system.

Areas Covered in this Webinar:

  • FDA QSR Requirements for Purchasing
  • The Supplier Quality Agreement
  • Administrative Elements
  • Compliance
  • Manufacturing, Packaging, and Labeling
  • Documentation and Records
  • Storage and Shipment
  • Change Control
  • Non-Conformance, CAPA, and Complaints
  • Auditing

Who will benefit:

This webinar provides valuable information for those involved in supplier management in the medical device industry.

People in the following roles can especially benefit from the knowledge in this webinar:

  • Medical Device Quality Managers
  • Regulatory Affairs Managers at medical device companies
  • Risk Managers
  • Medical Device Supply Chain Managers
  • Purchasing Professionals
  • Medical Device Supplier Management Team

Instructor Profile:

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 holds an APICS certification in Resource Management.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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