Course Overview:
This training will provide participants with an understanding of the requirements for good distribution
practice for medical devices.
Course Objective:
At the end of this course, participants will be able to:
• 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
Course Outline:
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Day 1
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Section 1
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Introduction
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Section 2
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GDPMD Requirements
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Part 1- Preliminary
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Part 2- Organization and GDPMD Regulatory Compliance System
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Part 3- Establishment Responsibility
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Part 4- Resource Management
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Part 5- Supply Chain and Device Specific
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Part 6- Surveillance and Vigilance
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Section 3
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Quiz
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Learning Methodology:
This course is highly interactive and utilizes various methodologies, including group discussions, case studies, role play, indoor games, video presentations, participant presentations, and group and individual challenges (where applicable).