Certification Program on Advanced Sterilisation and the Aseptic Presentation of Medical Devices – Cab/Notified Body Perspective

Introduction

The objective of the PSDC-IESCP Certification Program on Advanced Sterilisation and the Aseptic Presentation of Medical Devices – Cab/Notified Body Perspective is to equip participants with both foundational knowledge and broad appreciation of the sterilisation [with emphasis on Ethylene Oxide (EtO) and Irradiation] and the aseptic presentation from the CAB/notified body auditor’s frame of reference.

  • Fundamentals of Medical Device Safety
  • Risk Management, Risk-Based Approach, and the Sterilisation and Aseptic Presentation of Medical Devices
  • Usability Engineering in the Aseptic Presentation of Medical Devices
  • Basics of Sterilisation and the Aseptic Presentation of Medical Devices and Related Standards, Specifications, and Code of Practices
  • Cleanroom, Control Environments, and Hygiene Practices
  • Participants must be Malaysian
  • Participants must be from a HRDF levy-contributing company
  • Participant are not allowed to withdraw from the Program once their registration is approved
  • Participants must attend all training sessions and pass the written test to obtain the certificate
  • Participants are required to complete the Tracer Study
  • Duration
    8 Days
  • Date
    10 – 11 April, 17 – 19 April, 15 – 17 May 2018
  • Time
    9.00 am – 5.00 pm
  • Course Fee
    Course fees are fully funded by HRDF through the INBASE scheme
For Enquiries

For further information, please contact Marie Ngan (ext 577/mariengan@psdc.org.my) or Prethiba (ext 595/prethiba@psdc.org.my).