13-14 July 2021: Good Distribution Practices for Medical Devices (GDPMD)

Good Distribution Practices for Medical Devices (GDPMD)
This course is non-HRDF Claimable.

DATE
13-14 July 2021

TIME
1.30pm-5.30pm

DURATION
2 half-day courses (4 hours per session)

DELIVERY MODE
Online Training

INTRODUCTION

GDPMD is a stipulated requirement under the Malaysian Medical Act and its accompanying Regulations affects parties involved in the distribution of medical devices (authorized representatives, importers & distributors). This course provides an introduction and interpretation of GDPMD and related guidelines.

COURSE OBJECTIVES

  1. Understand GDPMD requirement that is applicable for relevant functions and activities within the establishment.
  2. Understand the role and responsibility of establishment, management teams, and individual employee in supporting GDPMD.
  3. Able to perform gap analysis, plan, establish and maintain an effective GDPMD within the establishment.

 

METHODOLOGY

  1. Materials / slide presentation and sharing
  2. Case study
  3. Interactive discussion

 

COURSE OUTLINE

  1. Medical device regulatory framework and GDPMD
  2. Roles and responsibilities of the establishment, management team and management representative
  3. Resource management and the support to GDPMD
  4. Supply chain activities, stock management, distribution record and the critical elements in GDPMD
  5. Device specific requirement
  6. Outsourced activities and control measures
  7. Secondary assembling requirement and control measures
  8. Product complaint handling
  9. Field corrective action
  10. Mandatory problem reporting
  11. Internal audit (a more detail training will be covered under GDPMD Internal Auditor training program)
  12. Corrective action and preventive action

TARGET AUDIENCE

Personnel who are:

  1. policy / decision maker, management team in an establishment
  2. responsible for GDPMD planning, execution and maintenance
  3. involved in supporting GDPMD operation
  4. in the function of quality, regulatory, supply chain, warehousing, purchasing, internal audit etc.

PRE-REQUISITES

To enhance the training effectiveness, trainer will require trainee or its representative to provide information which will help trainer in preparing effective training materials that best meet the needs of the trainees. Upon confirmation of training engagement, trainer will provide questionnaire for trainees to fill up. If there is a need, a short meeting may be arranged to facilitate discussion.

Chiew Teng (CT) or also known by the industry stakeholders as “Chuah” is a passionate and result-orientated regulatory professional. She has over 20 years’ experience – spanning the industry of medical devices, pharmaceutical, personal protective equipment (PPE), communication equipment and chemicals.

CT is passionate about providing timely support and aligning with clients’ goals for product launches and ensuring strategic approaches to regulation. CT has also demonstrated success in coaching and leading high-performing teams in her career. Her teams have achieved many regulatory milestones. CT’s vast experience in regulatory hands-on as well as leadership roles enables her to provide clients with a sustainable total solution for regulatory compliance and conformance.

Early Bird Prices (Register by 27 June 2021)
AMMI Member: RM636.00 per pax (incl 6% SST)
MMDA Member: RM636.00 per pax (incl 6% SST)
Non Member: RM 742.00 per pax (incl 6% SST)

Normal Fees (Register from 28 June 2021 onwards)
AMMI Member: RM 742.00 per pax (incl 6% SST)
MMDA Member: RM 742.00 per pax (incl 6% SST)
Non Member: RM848.00 per pax (incl 6% SST)

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 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.

Option 2: Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with the payment link will be sent to your email address separately when you choose this option.

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