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Trista Tan
- ISO Standards
- 2 days
INTRODUCTION
It is essential to equip our people who is playing the leading role in an organization with appropriate understanding and appreciation in the application of SS 620:2016 (2021) Good Distribution Practice for Medical Devices – Requirements in order to lead and supervise their subordinates on the shop-floor effectively and efficiently.
COURSE OBJECTIVE
(a) To equip the participants with the basic knowledge and skills to implement Good Distribution Practice for Medical Devices into their business operation.
(b) To enable the participants to conduct their internal audit in accordance with ISO 19001:2018 Guidelines.
Course Duration
2 days | 9am – 5pm | 14 hours
WHO SHOULD ATTEND?
This program is designed for Supervisors, Executives, Engineers and Managers who are
involved in managing the day-to-day operational activities and engaged in routine internal
audits.
Course Fees
Member: S$782.62
Non-Member: S$867.64
Registration Fee of S$17.44 apply
All fees stated are inclusive of Registration Fee and 9% GST.
Award of Certificate
Certificate of Attendance will be issued to participants who have attended at least 75% of the course.
Course Content
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Day One: SS620:2016 – Good Distribution for Medical Devices-Requirements
- Scope
- Normative References
- Terms and Definitions
- Quality Management System
- Management Responsibility
- Resource Management
- Premises and Facilities
- Secondary Assembly
- Traceability
- Counterfeit, Adulterated, Unwholesome or Tampered Medical Devices
- Complaint Handling
- Field Safety Corrective Action (FSCA)
- Internal Audit
- Outsourced Activities
- Class-room Exercise & Discussion
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Day Two: ISO 19011:2018 Guidelines for Auditing
- Part 1: Auditing Requirements
- Part 2: Auditing Exercise
Trainer
