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About Us
About SQI
Chairman’s Message
Quality Policy
Constitution
Executive Council
Structure
Testimonials
Membership
Courses
Consultancy
Training Calendar
Events
Upcoming Events
Contact
enquiries@sqi.org.sg
+(65) 6467 4225
SS 620:2016 (2021) Good Distribution Practice for Medical Devices – Requirements & Internal Auditor Training Course
Curriculum
2 Sections
17 Lessons
2 Days
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Day One: SS620:2016 – Good Distribution for Medical Devices-Requirements
15
2.1
Scope
2.2
Normative References
2.3
Terms and Definitions
2.4
Quality Management System
2.5
Management Responsibility
2.6
Resource Management
2.7
Premises and Facilities
2.8
Secondary Assembly
2.9
Traceability
2.10
Counterfeit, Adulterated, Unwholesome or Tampered Medical Devices
2.11
Complaint Handling
2.12
Field Safety Corrective Action (FSCA)
2.13
Internal Audit
2.14
Outsourced Activities
2.15
Class-room Exercise & Discussion
Day Two: ISO 19011:2018 Guidelines for Auditing
2
3.1
Part 1: Auditing Requirements
3.2
Part 2: Auditing Exercise
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