16,17 and 18 November: MDSAP Intermediate

Medical Device Single Audit Program (MDSAP)
Intermediate Level

Dates:

16, 17 and 18 November 2021

Time:
8.30am – 5.30pm (3 full days)

Delivery Mode
Online Training

INTRODUCTION

The Medical Device Single Audit Program (MDSAP) was the initiative from the International Medical Device Regulators Forum (IMDRF). Developed to enhance the auditing and monitoring approach of medical devices manufacturing globally, MDSAP went through a 3-year pilot project from 1st January 2014 until 31st December 2016 and became a full program from 1st January 2017.

 

There are currently 5 MDSAP members and they are:

  1. Therapeutic Goods Administration (TGA) of Australia
  2. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA)
  3. Health Canada (HC)
  4. Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
  5. S. Food and Drug Administration (FDA)

 

The MDSAP requirements are developed based on the 5 MDSAP members’ country’s regulated policies for medical devices with ISO 13485 Quality Management System requirements as the basis. MDSAP certification audit is performed by approved and authorized Auditing Organizations (AO) and the MDSAP certification is on a 3-year cycle.

 

COURSE OBJECTIVES

This course aims to give delegates in-depth knowledge regarding the Medical Device Single Audit Program (MDSAP) and the course content outlined is to provide delegates with information on:

  • The background of MDSAP
  • MDSAP members
  • The MDSAP Companion Document
  • The 7 processes in MDSAP and their interlinkages
  • Auditing Organization (AO) and the MDSAP Certification
  • The MDSAP audit approach and audit time determination

 

COURSE OUTLINE

Session 1

Opening and introduction

  1. Background of Medical Device Single Audit Program (MDSAP)
  2. MDSAP members, Official observers and Affiliate members
  3. The 7 processes in the MDSAP
  4. Management
  5. Device Marketing Authorization and Facility Registration
  6. Measurement, Analysis and Improvement
  7. Medical Device Adverse Events and Advisory Notices Reporting

 

Session 2

  1. The 7 processes in the MDSAP (Continue)
  2. Design and development
  3. Production and Service Controls

 

Session 3:

  1. The 7 processes in the MDSAP (Continue)
  2. Purchasing
  3. Auditing Organization and MDSAP Certification
  4. The MDSAP audit approach and audit time determination
  5. Course summary

 

COURSE BENEFITS

Upon completion of this training, delegates will: –

  1. Be able to understand the structure and purpose of MDSAP
  2. Have knowledge on the 7 processes in MDSAP and its interlinkages
  3. Be able to understand Auditing Organization’s (AO) responsibilities
  4. Be able to understand the audit approach for MDSAP based on the guidance document

Have knowledge on MDSAP certification and its benefits

 

DURATION

3 full days course running from 8.30am to 5.30pm with 1 hour lunch break in between.

MODE OF TRAINING

Online Training

 

TARGET AUDIENCE

This program is useful to delegates who are managing Medical Device Single Audit Program (MDSAP) compliances as well as internal auditors who are also auditing the MDSAP’s scope.

Kenny Chong is the General Manager at Quintas Consulting Sdn Bhd where his role also includes maintaining top quality training, consultancy and coaching service for Medical Device & other regulated industries.

He has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics, Symmetry Medical, Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes. He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016.

COURSE FEES

Early Bird Course Fees (Register by 15 October 2021)
AMMI Members: RM1,908 per pax (inc 6% SST)
Non-AMMI Members: RM2,226per pax (inc 6% SST)

Normal Course Fees (Registration from 16 October 2021 onwards)
AMMI Members: RM2,226 per pax (inc 6% SST)
Non-AMMI Members: RM2,544 per pax (inc 6% SST)

PAYMENT AND CONFIRMATION OF REGISTRATION

Option 1: HRDCorp Claim under SBL-Khas 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.

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