NCR/CAPA/Complaint Handling

LIMITED SEATS – REGISTER NOW! 15-16 April  2020, Penang

NCR/ CAPA/ Complaint Handling

Date: 15-16 April 2020
Venue: AC Hotel, Penang
Time: 9.00am – 5.00pm

COURSE FEE
AMMI Member: RM 1,272  nett per pax
Non Member: RM 1,484 nett per pax

INTRODUCTION

This course introduces the concepts needed to understand the requirements of USFDA 21 CFR Part 820 and ISO 13485:2016 related to NCR, CAPA & Complaint Handling.

COURSE OUTLINE

  1. USFDA 21 CFR Part 820
  2. ISO 13485:2016
  3. Terms and definitions
    3.1. General definitions
    3.2. NCR
    3.3. CAPA
    3.4. Complaints (Handling)
  1. Sources of NCRs, CAPAs and Complaints
    4.1. NCR
    4.2. CAPA
    4.3. Complaints
    4.4. Selection criteria NCR/CAR/CAPA

 

  1. Structure, templates, details (8D……)
    5.1. NCR
    5.2. CAPA
    5.3. Complaints
  2. Root Cause analysis / Problem solving tools
    6.1. 5 Why, 1 How
    6.2. 5 W, 1 H
    6.3. Fishbone or Ishikawa diagram

 

TARGET AUDIENCE

Medical device quality professionals with knowledge of ISO 13485:2016 and FDA 21 CFR Part 820, individuals handling NCRs, CAPAs & Complaints and which are looking for improvements of their Quality Management Systems.

 

PRE-REQUISITES
An understanding of the ISO 13485:2016 and FDA 21 CFR 820 requirements and a minimum 6 months of work experience in the medical industry is recommended.

 

DURATION
Two (2) full days

TRAINER’S PROFILE

Frank Ried is a German national living and working in Malaysia for more than 20 years. He holds a Mechanical Engineering Degree (Dipl. Ing.) from University of Kassel/Hessen (Germany). Frank is a Quality Engineer and Quality Auditor certified by EOQ (European Organisation of Quality) and DGQ (Deutsche Gesellschaft fuer Qualitaet). He is trained as Lead Auditor for ISO 9001, ISO 13485 and USFDA 21 CFR Part 820 requirements and has vast experience auditing and setting up compliance systems in these areas.

Frank has over 30 years of professional experience in the Medical Device manufacturing, pharmaceutical, personal protection and condom industry. He worked in two companies (B. Braun and Ansell) and various departments during this time.

Frank left Ansell at the end of 2016 to concentrate on his own company, Ried Q&C Consulting Sdn. Bhd., which he founded in early 2015. Frank now provides consultation in the compliance areas of ISO 9001, ISO 13485 and QSR (FDA) for Medical Device companies in Malaysia as well as Asia Pacific, fully utilising his expertise and experience in Quality Management, Assurance and Control. He also conducts training course as well as internal audits (incl. Mock-FDA Inspections) and supplier audits.

PAYMENT AND CONFIRMATION OF REGISTRATION
All payment is due immediately upon receipt of invoice. Please note that a confirmation letter for HRDF submission will only be issued upon receipt of payment.

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration.  Please note that any Early Bird Discounts (for registration within the 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. A confirmation letter for your HRDF submission will be issued to you upon receipt of payment.

Please refer the following bank account details:

 

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. 

Option 2: Direct  Online Payment
You may choose to make a direct online payment, via Paypal or your credit/ debit card. A tax invoice and confirmation letter will be sent to your email address within 3 working days, when you choose this option.

CANCELLATION / REFUND POLICY
AMMI 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.  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 the 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 secretariat@ammi.com.my
Tel: +6010 4040 662  Fax: +603 2178 4347