Course Objectives
Good Distribution Practice For Medical Devices (GDPMD) Awareness And Internal Audit Training: Malaysia imposes the Medical Device Regulation 2012 for medical devices industry and thus the related organisations are required to set up and comply with the regulation.
- In this GDPMD training, the participants will be guided with the explanation and discussion on each requirements of GDPMD so that they are able to understand and implement the regulation effectively. This GDPMD training is to guide the participants with the knowledge and skill to establish the GDPMD regulatory system in their organization.
Who Should Attend
This GDPMD course is designed for individuals in the medical device local authorized representative, distributor and importer who are involved in the development and maintenance of a quality management system based on GDPMD
No prerequisites are necessary for this GDPMD course.
How You Will be Benefit
- Champion GDPMD benefits
- Fulfill GDPMD standard / regulatory requirements.
- Give participants an awareness of GDPMD and its alignment
- to respective Quality System Regulation
- Assist participants in the relationship between QMS and registration
- Identify what GDPMD and also what is regulatory expectation
Solutions
- This GDPMD course can be run in-company around the world
- We can tailor the content to focus on your requirements.
- This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
- Classroom accompanied by Lectures, Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
- Delegate manuals and certificates of Attendance will be provided
Course Content
Day 1
Session 1: Introduction of Medical Device and GDPMD (Good Distribution Practices for Medical Device)
- As a start, participants will be presented with the fundamentals, brief concepts, purposes, set up, certification and audit flow as well as the application of the regulation in Medical Device industry nationally and internationally.
Session 2: GDPMD: Part 1 and 2
- Participants will be guided with the explanation of the requirements in the Part 1 (Preliminary) and Part 2 (Regulatory Compliance System).
Session 3: GDPMD: Part 3 and 4
- Participants will be guided with the explanation of the requirements in the Part 3 (Establishment Responsibilities) and Part 4 (Resource Management).
Session 4: GDPMD: Part 5 and Part 6
- Participants will be guided with the explanation of the requirements in the Part 5 (Supply Chain and Device Specific) and Part 6 (Surveillance and Vigilance).
Q&A
End of the Day 1 session
Day 2
Session 5: Internal Audit Based on GDPMD
- Initiating an audit
- Document Review
- Audit Plan
- Audit Work Documents
- Opening Meeting
- Execute the audit
- Documenting Non-conformities
- Closing Meeting
- Audit Report
- Audit Follow-up
