ONLINE TRAINING BY THE AUTHORITY GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)

ONLINE TRAINING BY THE AUTHORITY

GOOD DISTRIBUTION PRACTICE FOR MEDICAL DEVICES (GDPMD)

 

Date	:	13th - 14th April 2022 (Two days)
Time	:	8.30 AM – 5.00 PM
Platform	:	Online Training

 

 

INTRODUCTION

This online training is to provide an understanding of the MDA/RR No. 1, Good Distribution Practice for Medical Devices (GDPMD), addressing requirements in the medical device supply chain, which include, but are not limited to, product sourcing and procurement; transportation and delivery; storage; installation, commissioning, service and maintenance, calibration and after-sales service; tracking, documentation and record-keeping practices.

In order to carry out activities relating to medical devices, certification to GDPMD is required for establishments such as Authorised Representatives, Importers, and Distributors in applying for establishment license. This is to ensure the safety and performance of medical devices are preserved post-manufacturing until their disposal.

This training aims to help participants in understanding the scope and use of GDPMD in complying with the Medical Device Regulations and to assist participants intending to pursue GDPMD certification.

 

OBJECTIVES

• To provide an overview and interpretation of the clauses of GDPMD
• To understand the scope and use of GDPMD in meeting the requirements of Medical Device Regulations
• To highlight the importance of GDPMD
• To understand the procedures and supporting documents to be developed in pursuing GDPMD certification
• To understand on implementation of the GPDMD system as part of daily operations
• To gain understanding and insights in establishing the GDPMD system in their own organizations

 

TARGET AUDIENCE

• Medical Device Industry (Authorized Representative, Distributor, Importer)
• Quality managers and regulatory affairs personnel
• Conformity Assessment Bodies (CABs);
• Internal and external auditors
• Other Medical Device Industry players
• Anyone involved with the implementation of the GDPMD
• Designated persons
• Interested individuals

 

PROGRAMME OUTLINE

DAY 1
Date (Day)	13th April 2022 (Wednesday)
Time	Topic
08.30 AM	Registration
08.50 AM	Briefing
09:00 AM	Medical Device Regulatory Requirements
10:30 AM	Break
10:45 AM	Ice breaker
11:00 AM	Overview of Good Distribution Practice for Medical Devices (GDPMD) Part 1: Preliminary
11:30 AM	Part 2: Organization and GDPMD Regulatory Compliance System
12:00 PM	Part 3: Establishment Responsibilities
12:30 PM	Part 4. Resource Management
1:00 PM	Lunch Break
02.30 PM	Part 5. Supply-chain and Device Specific
03.30 PM	Break
03:45 PM	Part 6. Surveillance and Vigilance
04.45 PM	Q & A session
05.00 PM	End of Day 1

 

DAY 2
Date (Day)	14th April 2022 (Thursday)
Time	Topic
08.30 AM	Registration
08.50 AM	Briefing
09:00 AM	Case study
10:30 AM	Break
10:45 AM	Presentation by groups
12.30 PM	Q & A session
1:00 PM	Lunch break
2.30 PM	Briefing for examination and revision by participants
3:15 PM	Examination
4:30 PM	Wrap up
5.00 PM	End of Day 2

 

 

OUR TRAINER

Ir. Shamila graduated from Universiti Putra Malaysia (UPM) with a Bachelor’s Degree (Hons) in Electrical/Electronic Engineering in 2000. She started her career with TriSystems Engineering Sdn Bhd in February 2001, as an Engineer and resigned as Project Engineer in 2004. Ir. Shamila was selected to represent Malaysia at the International Association of Traffic and Safety Sciences (IATSS) Forum, a 55-day leadership training program in Japan for young professionals from Asian countries hosted by Honda Motor Corporation, Japan. After she returned from IATSS Forum in 2004, she joined Matsushita Toshiba Picture Display (M) Sdn Bhd as the Safety and Health Engineer, a position which she held from August 2004 – March 2007. She completed and passed her Safety and Health Officer Training with NIOSH in October 2006. Concurrently, she pursued her Master of Business Administration from the University of Strathclyde part-time and graduated in 2008. She joined Subang Jaya Medical Centre in April 2007, now known as Ramsay Sime Darby Healthcare Hospitals as a Quality Executive. She rose through the ranks from an Engineer to Manager of the Biomedical Engineering Department before resigning to form her own company. Now she is self-employed under Armamentarium Consulting as a Freelance Healthcare & Biomedical Engineering Consultant, Trainer, and Auditor.

 

REGISTRATION AND TRAINING FEE

• The closing date for registration is on 8^th APRIL 2022.
• Training fee per participant: RM 2,000.00
• To register, please click HERE
• Upon acceptance of the Registration, an invoice (for payment purpose) together with details of the payment method will be issued accordingly
• Registration of participants will be on a first-come-first-served basis.
• Limited to 150 participants.
• Upon payment confirmation, MDA will provide a link to join the training program.
• Once paid, the registration fee is non-refundable.

CONTACT

For enquiries, please contact trainingpackage@mda.gov.my or 03-8230 0240 / 0355 / 0211

 

 

 

 

 

Updated: 23 March 2022