18-19 July 2022: NCR/CAPA/ Complaint Handling

NCR /CAPA/ COMPLAINT HANDLING

Date: 18-19  July 2022

Time: 8.30am – 5.30pm

Delivery Mode
Online Training

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.

 

DURATION

2 full days

 

MODE OF TRAINING

Online

 

TRAINER PROFILE

Harry Wong has over 19 years’ of professional work experience in Quality Assurance of medical device, Ceramic Former and Metal Stamping for Electrical, Electronics and Automotive industries. He currently holds the position of Associate Director, Global Complaint and Risk Management, Global Quality Assurance in one of the global leaders in protection solutions. As the subject matter expert of risk management, he provides advice, direction and training for Risk Management personnel across global sites and facilities; ensuring their risk management process complies with all necessary regulatory standards including QSR (FDA), MDD and ISO requirements. He is responsible for developing the global harmonized risk management SOP and tools which are implemented in the global organization facilities and sites.

Harry Wong is also an ASQ Certified Quality Engineer and Lead Auditor for ISO 9001 and ISO 13485 and has extensive involvement in mock audits for global sites preparing for CCC, ANVISA, SEI and FDA.

COURSE FEES

Early Bird Course Fees (Register by 24 June 2022)
AMMI Members: RM1,272 per pax (inc 6% SST)
Non-AMMI Members: RM1,484 per pax (inc 6% SST)

Normal Course Fees (From 25 June 2022 onwards)
AMMI Members: RM1,484 per pax (inc 6% SST)
Non-AMMI Members: RM1,696 per pax (inc 6% SST)

Sign up for more than 6 pax, and enjoy special Group Registration Fee and Bonus Deal.

  • Group Registration Package:
    For group registration of 6 pax and above (up to 9 pax), the fee is RM1,166 per pax (inc 6% SST).
  • Bonus Deal Package:
    For group registration of 10 pax and above (up to 18 pax), the bonus deal are as follows:
    – First 9 pax: RM1,166 per pax (inc 6% SST).
    – 10th pax – 18th pax: RM212 per pax (inc 6% SST).

PAYMENT AND CONFIRMATION OF REGISTRATION

Option 1: HRD Corp Claimable Course Scheme

A quotation together with course outlines and course agenda will be sent to you for HRDCorp grant application upon confirmation of the training. Please send us the grant application number for our record upon submission.

 

Option 2: Self-paying

2a) Direct Bank-in or via E-Banking

An invoice will be sent to you within 3 working days upon your registration. Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.

 

Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd

Bank Account Number: 230-302-078-2

Bank: UOB Bank

Swift Code: UOVBMYKL

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed.

 

2b) Direct Online Payment

You may choose to make credit card payment via Paypal. An invoice with payment link will be sent to your email address separately when you choose this option.

CANCELLATION / REFUND POLICY
The organisers, AMMI/ Medsociate Sdn Bhd reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded in full if the cancellation is made by AMMI/ Medsociate Sdn Bhd. No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

SUBSTITUTION

Replacement of participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

CONTACT

For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347