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

PREREQUISITE

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.

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.