SS620:2016 (2021) Good Distribution Practice for Medical Devices Internal Auditor Training Course

Description

The course aims to impart the skills and knowledge in conducting internal audits against GDPMDS and the relevant guidance documents.

Objectives

This 2-Day course is designed primarily to provide participants with the knowledge and skills required to perform internal audits of the SS GDPMDS standard, in accordance with ISO 19011.

The delegates will understand the key changes in SS 620: 2016 (2021) and reference to relevant guidance documents.

Course Content

• Medical Device Regulatory Framework

• Classification of Medical Devices and Background of SS GDPMDS

• GDPMDS Requirements vs ISO 9001 Requirements: Clauses 1 to 14

• Workshop

• Plan and conduct an audit

• Report the audit

• Undertake audit follow-up activities

Audience

• Managers / executives / personnel who are involved in organizing and conducting internal audits for GDPMDS

• Personnel who are involved in the implementation and maintenance of SS GDPMDS or those who wish to know more about the specification and its requirements.