SS 620:2016

Good Distribution Practice For Medical Devices (GDPMDS) Internal Auditor Course

PRICE
SGD$700
[Subject to 7% GST]

DURATION
2 Days

LANGUAGE
English

CODE
MM-70221

WHO SHOULD ATTEND
Quality Manager, SS 620:2016 Appointed Internal Auditor, Individual responsible for establishing, implementing, maintaining SS 620:2016

This course aims to equip learners with the knowledge and skill to perform 1st party and 2nd party audits on Good Distribution Practice for Medical Devices (GDPMDS) Management System in accordance with SS 620:2016 Standard.

Step up professional competencies and gain global recognition.

Downloadable Resources

Course Content

Day 1

  • Overview of SS 620:2016 requirements
  • Reason for changes from previous HSA TS-01 to SS 620
  • Understanding Requirements of Quality Management System – Organization Context
  • Documentation Control
  • Support and Resource Management
  • Operation Control (i.e., Storage, Premises and Facilities, Delivery, Installation and Servicing Activities, Calibration, Return and Disposal of Medical Devices)
  • Secondary Assembly
  • Traceability of medical devices
  • Management of non-conforming medical devices
  • Complaint handling and Field Safety Corrective Action
  • Management of Outsourced Activities

Day 2

  • Auditing Principles
  • Audit Objectives
  • Internal Audit Processes:

(A) Stage 1: Audit Preparation

– ISO 19011:2018 Guideline for Auditing Management Systems

– Determine Audit Scope

– Forming Audit Team

– Establish Audit Plan

(B) Stage 2: Conduct of Audit

– Evidence Gathering, Interview, Site Inspection & Document Review

– Triangulation of Facts

– Categories of Audit Findings

(C) Stage 3: Report Findings and Follow Up

– Closing Meeting

– Writing audit finding statement

– Preparation of Audit Report

– Follow up on Corrective Action on audit findings closure

Mode of Training*

1. Online Webinar (With interactive activities using Mentimeter/Kahoot/Breakout rooms to equip learners with an active learning experience.)

2. Face-to-Face (Live interaction with the trainer during group discussions, operational case study, individual and group presentation on the course activities assigned.)

*Mode of training may vary based on Covid-19 advisory or pandemic situation. Please refer to the course registration form for the confirmed mode of training for the respective dates.

Assessment & Certification

Participants to attend MCQ Assessment upon course completion.

Certification will be issued to participants who have attended the course and have successfully completed the assessments.

Need Any Assistance?

For more specific information on the course details and schedule, do get in touch with us. We are also able to customise a course for your company.