Supplier management - initial selection and ongoing assessment - is a critical issuesfor medical device manufacturers. Suppliers provide components and/or services to the legal manufacturer, which means they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

·  How well do you understand the requirements for supplier management?

·  Could you host a regulatory audit or inspection without any issues?

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This 6-hour course provides a clear understanding of the underlying principles of supplier management. As part of the practical implementation, the course discusses receiving acceptance activities, outsourced processes, and process validation at the supplier’s location.

In addition to the discussion material, the course includes templates and tools to help you implement an effective program.

Learning Objective:

Upon course completion, participants will:

·  Understand FDA QSR and ISO 13485 requirements for supplier management

·  Understand when suppliers have to register and list with the FDA

·  Understand the use of a risk-based approach to classify suppliers

·  Develop an overall supplier management plan

·  Understand how to develop and implement supplier controls

·  Create receiving inspection criteria and apply them as part of supplier controls

·  Create supplier measurement and monitoring systems

·  Create a risk-based approach to select and assess suppliers

Who will Benefit:

·  Quality Managers

·  Supply Chain Managers

·  Supplier Quality Engineers

·  Purchasing Professionals

·  Regulatory Specialists

·  Production and Process Engineers

·  Verification and Validation Specialists