Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme

NCR, CAPA & Complaint Handling

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.

 

For enquiries, email to admin@medsociate.com