SS 620:2016 (2021) Good Distribution Practice for Medical Devices – Requirements & Internal Auditor Training Course

Course Content

Total Training Hours: 2 days

  • Day One: SS620:2016 – Good Distribution for Medical Devices-Requirements   0/15

    • Lecture1.1
      Scope
    • Lecture1.2
      Normative References
    • Lecture1.3
      Terms and Definitions
    • Lecture1.4
      Quality Management System
    • Lecture1.5
      Management Responsibility
    • Lecture1.6
      Resource Management
    • Lecture1.7
      Premises and Facilities
    • Lecture1.8
      Secondary Assembly
    • Lecture1.9
      Traceability
    • Lecture1.10
      Counterfeit, Adulterated, Unwholesome or Tampered Medical Devices
    • Lecture1.11
      Complaint Handling
    • Lecture1.12
      Field Safety Corrective Action (FSCA)
    • Lecture1.13
      Internal Audit
    • Lecture1.14
      Outsourced Activities
    • Lecture1.15
      Class-room Exercise & Discussion

  • Day Two: ISO 19011:2018 Guidelines for Auditing   0/2

    • Lecture2.1
      Part 1: Auditing Requirements
    • Lecture2.2
      Part 2: Auditing Exercise
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