INTRODUCTION

This course introduces the concepts needed to understand the requirements of NCR, CAPA & Complaint Handling under ISO 13485:2016 QMS and US FDA Quality System Regulation (21 CFR Part 820). And provide guidance on how to effectively address each of it with step-by-step process and root cause analysis & problem-solving tools.

COURSE OUTLINE

Introduction

• Definition
  • NCR
  • Complaint Handling
  • CAPA
• Standard and Regulatory perspective on NCR, Complaint Handling and CAPA.

NCR

• What is Nonconformance?
• Example of Nonconformance
• Nonconformance process flow
• Tips to Prevent Non-Conformance
• Sample Template for NCR

Complaint Handling

• What is customer complaint?
• Why do customer complaint?
• Complaint Handling Process
• Rules of Complaint Handling
• Tips of Effective Complaint Handling
• Sample Template for Complaint Handling

CAPA

• Intro
• What is CAPA
• Risk Based CAPA
• Problem of CAPA
• Why So Important
• Cause of Confusion
• Why Understand Difference So Important?
• What’s the Difference Between Correction, Corrective Action, Preventive Action?
• Steps to Create Risk Based CAPA Process
• Sample Template for NCR
• Learning from Experience- CAPA System Effectiveness
• How CAPA Connects to NC and Complaint Handling

ROOT CAUSE ANALYSIS

• Introduction
• Challenge in Root Cause Analysis
• Symptoms vs Cause of the Problem
• Contribution Factor vs Root Cause
• Root cause analysis problem solving model
• Root Cause Analysis Tools
• Root Cause Analysis in A Regulated Environment

TARGET AUDIENCE

Medical device quality professionals with knowledge of ISO 13485:2016 and FDA 21 CFR Part 820, individuals handling NCRs, CAPAs & Complaints, and those who news to medical device industry and would like to have better understanding on Nonconformance (NC), Complaint Handling and Corrective & Preventive Action (CAPA) to facilitate their implementation and improvements of their Quality Management Systems.

PRE-REQUISITES
An understanding of the ISO 13485:2016 and FDA 21 CFR 820 requirements is an advantage (not compulsory) and has work experience in the medical industry is recommended.