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.
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?
Supplier-Related Corrective and Preventive Action, Continuous Improvement, and Development
Supplier Quality Agreements
Supplier Contract and Agreement Administration
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
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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