Supplier Quality Management - Implement it Now or Pay for it Later
June 3, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Overview: Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Aside from the regulatory implications for failure to comply with FDA's requirements, not assessing and monitoring your suppliers can result in product recalls, high levels of complaints, potential patient/user injuries and deaths, and expensive lawsuits. Not explicitly defining the responsibilities of your suppliers can lead to adulterated and misbranded product, as well as unnecessary costs associated with cost of good and overhead. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer. This webinar will provide attendees with the information and tools necessary to develop, implement, and effectively utilize and maintain a program for Supplier Quality Management that will satisfy the FDA's requirements without creating undue burdens for the organization. Learning Objectives: Understand the FDA's requirements for medical device supplier assessment and approvals. "Who" are considered to be suppliers? How to structure a Supplier Quality Agreement What are the potential methods for evaluating and assessing suppliers? Areas Covered in the Session: Supplier Quality Management Overview Supplier Selection, Approval, and Disapproval Supplier Evaluation and Performance Monitoring Supplier Approval Status: Approved, Conditional, Disapproved, Probationary Supplier Change Control Supplier-Related Corrective and Preventive Action, Continuous Improvement, and Development Supplier Quality Agreements Supplier Contract and Agreement Administration Supplier Records Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1PL9Y24 support@compliance4all.com www.compliance4all.com