Purchasing Controls Introduction

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

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