GDPMD Requirements and Documentation Training & Workshops
Understanding of Good Distribution Practice for Medical Devices (GDPMD) Requirements and Documentation Training & Workshops
Training Total Day & Time: 2 Days (9.00am to 5.00pm)
Objective of the Course:
- Understand the concept, process approach, documented information, and key requirements of Good Distribution Practice for Medical Devices (GDPMD).
Who should attend:
- Managing Director/ General Manager/ Top Management
- Head of Departments/ Sections
- Key personnel/ Supervisor/ GDPMD Team Members
- Internal auditors
Training agenda:
| Day1 |
9am~1pm |
- What is GDPMD?
- Why GDPMD?
- Understanding of GDPMD requirements
Part 1: Preliminary
- Objective
- Scope and application
- Definitions
Part 2: Organization and GDPMD Regulatory Compliance System
- Organization
- GDPMD regulatory compliance system
Part 3: Establishment Responsibilities
- Responsibilities and authorities
- Designated person
- Management review
- Review input
- Review output
|
| |
1pm~2pm |
Lunch Break
|
| |
2pm~5pm |
Workshop 1: Determine processes of GDPMD management system (50 minutes)
Presentation and practical comments for learning.
Part 4: Resource Management
- Personnel
- Training, competency, and awareness
- Infrastructure
- Work environment
- Cleanliness and pest control
|
| Day2 |
9am~1pm |
Part 5: Supply Chain and Device Specific
- Authorization
- Communication channels
- Receipt of stock
- Storage and stock handling
- Stock rotation
- Delivery to customers
- Control of nonconforming medical devices including returned medical devices
- Disposal of medical devices
- Traceability
- Specific requirements for active medical devices
- Outsourced activities
- Counterfeit adulterate, unwholesome, and tampered medical services
- Secondary assembly including repackaging
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| |
1pm~2pm |
Lunch Break
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| |
2pm~5pm |
Workshop 2: Corrective action reporting for field corrective action (FCA) (50 minutes).
Presentation and practical comments for learning.
Part 6: Surveillance and Vigilance
- General
- Medical device complaints
- Distribution records
- Field corrective action (FCA) and field safety notice (FSN)
- Recall
- Mandatory problem reporting
- Internal audits
- Corrective action
- Preventive action
End of Training
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Contact us for information
Revision No.: 1 SM Effective Date: 1/8/2025
