Supplier Quality Management: Implement it Now or Pay for it Later

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

Why Should You Attend:

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 mis-branded 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.

Areas Covered in the webinar:

• 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

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?

Who Will Benefit:

This webinar will provide valuable assistance to the following departments of medical device manufacturers:

• 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
• Medical Device Suppliers
• Medical Device Contractors, OEMs

Instructor Profile:

Les Schnoll, is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program. He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at ThermoGenesis, Theravance, Solectron, Hill-Rom, Gliatech, Cyberonics, Southern Research Institute, KPMG Quality Registrar, and Dow Corning Corporation. Les has conducted various training programs, audits, and systems development in the United States, Canada, Europe, South America, Russia, Australia, and the Pacific Rim.

Schnoll has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.

Les has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration in human resources from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.

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