GDPMD certification is a mandatory requirement for the authorized representatives of foreign manufacturers, importers or distributors of medical device in Malaysia as per the Appendix 4 of Schedule 3 of the Medical Device Regulation 2012. GDPMD specifies the requirements for a quality system to be established and maintained by an organization in carrying out activities in the medical devises supplychain. 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.
How will i benefit?
This course will help you:
- Gain an understanding of the GDPMD requirements.
- Help your organization to regulate each stage of the distribution chain of
medical devices. - Fulfil the requirements of GDPMD throughout the supply chain of medical
devices. - Conduct internal audits against the GDPMD requirements.
- Write factual audit reports and suggest corrective actions
Who should attend?
Specially targeted to those responsible in development & implementation of GDPMD requirements including management representative, managers, executives, internal auditors, team leader and team members.
What will i learn?
On completion, you should gain the knowledge and skills to:
- Explain the structure and scope of GDPMD and how it applies to the
organization seeking regulatory compliance - Outline the key principles of auditing and auditor responsibilities
- Display skills to plan an internal audit and conduct an effective audit based on process identification, sampling and questioning
- Practice determining if corrective action has been effectively implemented
What is included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Prerequisites
You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction or Clause by Clause course.
