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Supplier Quality Management Webinar: Implement it Now or Pay for it Later
June 3, 2015 @ 10:00 am - 11:00 am
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
Who Will Benefit:
- Quality Assurance/Quality Control Directors, Managers, and Specialists
- Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists
- Purchasing/Materials Management Directors, Managers, and Specialists
- Engineering/Development Directors, Managers, and Specialists
- Document Control Managers and Specialists
Speaker Profile
Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.
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