TRAINING COURSES Industry Expert Learning Series HRDF-SBL Scheme Claimable
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
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
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
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 email@example.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