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Medical Device Supplier Quality Agreements

Course "Efficient Medical Device Supplier Quality Agreements" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

 

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Date & Time: Wednesday, June 20, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: Dan OLeary

Location: Online

Price : $245.00

Instructor Profile:

Dan OLeary President, Ombu Enterprises

(for one participant)

Dan 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. ...more

Overview: 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 webinar explains the elements of a supplier quality agreement and its 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. You need to understand the QSR requirements, good business practices, and the role of a quality agreement. This webinar will help you set up an effective system.

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Areas Covered in the Session: l

Valuable documents that provide understanding ¡ Quality System Regulation (QSR), including the ¡ ¡ ¡

definitions QSR Preamble ISO 13485:2003 FDA's Quality System Inspection Technique (QSIT)

manual Warning Letters Subject Areas covered ¡ QSR Requirements for Purchasing ¡

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¡ ¡ ¡ ¡ ¡ ¡ ¡

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 For each subject area, the webinar includes information from ¡ ¡

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the valuable documents listed above

Click here to register for this webinar Who Will Benefit: l l l l l l l

Quality Managers Regulatory Affairs Managers Risk Managers Supply Chain Managers Purchasing Professionals Supplier Management Team Customer Complaint Specialists

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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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Medical Device Supplier Quality Agreements  

The FDA’s Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and...

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