Course Description
This hands-on learning opportunity covers the key aspects of supplier controls – from planning for supplier assessment and selection, to defining acceptance activities and monitoring supplier performance – and links them to the requirements found in the ISO 13485 Standard, pertinent International Medical Device Regulators’ Forum (IMDRF) and Global Harmonization Task Force (GHTF) guidance. During this 1-day course, you will learn how to evaluate your organization’s compliance with FDA/ISO requirements for purchasing controls and acceptance activities, consider appropriate risk mitigation strategies for supplied products and services, and implement a life cycle management approach to your organization’s supply chain.
Who Should Attend
This course is designed for:
- Quality Managers
- Supplier Engineers
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Supplier Auditors
- Compliance Specialists
- Product and Process Engineers
- Design Engineers
Learning Objectives
Through training, participants will:
- Understand FDA and ISO13485 approach to Purchasing Controls
- Understand GHTF guidance
- Understand FDA Inspection Results via 483s and Warning Letters
- Gain an introduction into Good Supply Practices
- Develop a risk-based approach to supplier audits
Each topic is presented from a practical perspective, with links to the requirements of the QSR, the ISO 13485 Standard, risk management considerations, and pertinent GHTF guidance
Course Outline
- Introduction into ISO13485 and GHTF guidance requirements for Purchasing Controls
- Introduction to Good Supply Practices
- Understanding of Quality Agreement requirements to manage suppliers
- Risk Management mitigation strategies
- Review of FDA 483s and Warning Letters on Purchasing Controls
Prerequisites
A basic understanding of medical device purchasing controls
Course Format
8 hours
Virtual training with presentation and breakout sessions
Course Instructor: Courtland Imel
8:30am-4:30pm (EST)
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