To ensure the participant understands the right concept of GDPMD requirement and MDA requirement and to be able to apply to his/her “day to day” job in order maintain effective output of each process. To ensure the participant understands the right concept of GDPMD requirement and MDA requirement and to be able to apply to his/her “day to day” job in order maintain effective output of each process.
This 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 course.
The proposed course program is as following:
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).
Day 2
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).
Session 5: MDA regulations and guidance document related to GDPMD
Auditors
