INTRODUCTION

This course is designed for those with a working knowledge of medical device distribution practices. Participants will gain a broad understanding of Good Distribution Practice for Medical Devices (GDPMD) requirements together with associated regulatory requirements and guidance documents as well as internal audit methodology.

COURSE OBJECTIVES

1. Understand internal audit requirement in GDPMD.
2. Understand the role and responsibility of internal auditors and auditees.
3. Able to plan and conduct internal audit according to establishment’s activity and scope.
4. Able to process, analyse, finalize and follow through internal audit findings.

METHODOLOGY

1. Materials / slide presentation and sharing
2. Case study
3. Interactive discussion
4. Small group mock audit (if feasible, depending on establishment and participants’ arrangement)

COURSE OUTLINE

1. Understanding of Internal audit requirement in GDPMD
2. Establishment responsibilities for Internal audit
3. Establishment activities and relevant Internal audit scope
4. Roles and responsibilities of lead internal auditor, internal auditors and auditees
5. Internal audit skills, strategies, and techniques
6. Internal audit preparation and cycle
7. Internal audit findings and reporting
8. Issuance and closure of non-conformance report (NCR)
9. Internal audit improvement                           

DURATION

One (1) full day

MODE OF TRAINING

Remote Online Training or Classroom Training

PREREQUISITE

Participants are required to be trained on complete GDPMD requirement, prior to this GDPMD Internal Audit training.