The involvement of various organizations for the handling, transportation, storage, distribution and tracking of medical devices may pose risks to the products. The risks could be from the mix-ups, contamination as well as the counterfeit and tampered products.
Therefore, appropriate management and control shall be applied over these activities to ensure the maintenance of the quality and the integrity of the medical devices throughout the distribution process.
GDPMD specifies the requirements for a quality system to be established and maintained by an organization in carrying out activities in the medical devises supply-chain. GDPMD requires an organization to demonstrate its ability to maintain safety and performance of medical devices throughout the supply-chain. It will be used by both internal and external parties to determine the ability of an establishment to meet the requirements specified within.
This training will provide participants with an understanding of the requirements for good distribution practice for medical devices.
• Understanding the GDPMD requirements
• Awareness on the key elements to ensure medical device quality and safety along the supply chain.
• Understanding on the certification process
• What is GDPMD
• Introduction to GDPMD
• Quality Management System
• Management Responsibility
• Resource Management
• Supply Chain and Device Specific
• Vigilance and Corrective Action
• GDPMD Certification process
• Gain an understanding of the GDPMD requirements.
• Knowledge to implement and manage the system
• Sharing of experience with the tutor
Specially targeted to those responsible in development & implementation of GDPMD requirements including management representative, managers, executives, internal auditors, team leader and team members.