GDPMD Internal Auditor Training
INTRODUCTION
This course is designed for those with a working knowledge of medical device distribution practices and starts with a review of MDA/RR No.1. Participants will gain a broad understanding of Good Distribution Practices for Medical Devices (GDPMD) requirements together with associated regulatory requirements & guidance documents as well as internal audit methodology. This program uses an interactive approach to learning.
Participants will be led by an accomplished tutor with over 2 decades of auditing, training and quality assurance as well as management system development experience – including experience in assisting organisations in the implementation of the Malaysian GDPMD as well as GDPMDS (the Singaporean GDP which is similar (though not fully identical) to the Malaysian system). Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed to effectively manage audits. Participants will learn how to apply these principles to produce effective internal audits on Establishments and their Outsource Service Providers.
COURSE OBJECTIVES / OUTLINE
COURSE MATERIALS
Participants will receive comprehensive course manuals with reference materials
TARGET AUDIENCE
PRE-REQUISITES
Working knowledge of medical device distribution practices.
DURATION
Two (2) full days
CONTACT
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347
This course is designed for those with a working knowledge of medical device distribution practices and starts with a review of MDA/RR No.1. Participants will gain a broad understanding of Good Distribution Practices for Medical Devices (GDPMD) requirements together with associated regulatory requirements & guidance documents as well as internal audit methodology. This program uses an interactive approach to learning.
Participants will be led by an accomplished tutor with over 2 decades of auditing, training and quality assurance as well as management system development experience – including experience in assisting organisations in the implementation of the Malaysian GDPMD as well as GDPMDS (the Singaporean GDP which is similar (though not fully identical) to the Malaysian system). Participants will engage in small group activities and lively debate, along with instructor led segments to gain the expertise needed to effectively manage audits. Participants will learn how to apply these principles to produce effective internal audits on Establishments and their Outsource Service Providers.
COURSE OBJECTIVES / OUTLINE
- Gain an Overview of the GDPMD and Malaysian Medical Device Regulatory Requirements
- Recognize the Relationship between GDPMD and Quality Management Systems (QMS)
- Familiarise with Audit Interpretation of MDA/RR No.1
- Understand the Roles & Responsibilities of Authorized Representatives, Importers and Distributors in GDPMD as well as Post Market activities
- Apply Principles of ISO 19011 in the Auditing Processes
- Plan, Conduct, and Report Effective Internal Audits for Compliance to GDPMD
- Understand & Apply Principles of the Corrective Action Cycle
COURSE MATERIALS
Participants will receive comprehensive course manuals with reference materials
TARGET AUDIENCE
- GDPMD Auditors (Internal & External (3rd Parties)
- Auditors of Medical Device Supply Chain (incl. assessments on Supplier/Outsource Service Provider)
- Designated Persons (GDPMD)
- Personnel managing / conducting Post Market Surveillance & Vigilance
- Quality Managers
- Regulatory Affairs Managers
- Cross functional team members of system implementation projects
- Outsource Service Providers (e.g. 3PL, etc.) whose activities must meet GDPMD expectations
PRE-REQUISITES
Working knowledge of medical device distribution practices.
DURATION
Two (2) full days
CONTACT
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347