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ISO 11607 Training

Our training program covers ISO 11607, which sets out rules and testing methods for packaging medical devices that have been sterilized. It ensures the packaging works for sterilization, protects the device, keeps it sterile until you use it, and is safe for the materials. Following this standard is really important to make sure the device is safe, works well, and meets regulations.

Anchor ISO 11607

Course Objectives

At the end of the program participants should be able to do the following:
  • Understand the philosophy and principles of sterile barrier systems and packaging systems.

  • Aware of validation and routine control of the sterile barrier systems and packaging systems method and requirement.

  • Understand the key factors for sterilization process development.

Course Outline

Set the State- Overview:
•    Ice breaker- “Recognizing and Identifying STERILE            Product
•    Objectives of the workshop
•    Agenda
•    Administrative arrangement

Session 1: Overview of Sterile Barrier Systems and Packaging Systems


•    Introduction
•    Representative’s types of sterile barrier systems              and packaging systems
•    Packaging verification

Session 2: Key Factors of Sterile Barrier Systems and Packaging Systems Process Development


•    Packaging process validation
•    Awareness of ISO 11607-1 and ISO 11607-2
 

Target Audience

This program is very useful to participants who handles and are actively involved in Quality especially those who are QA/QC Lab technician, and QA/QC Executive.

Duration

2 full-day courses running from 8.30 am to 5.30 pm. Physical Training (On-site).

Training Fees

RM10,000 per session. Max of 15 pax per session. Additional RM700 for the subsequent participant (logistics and refreshments are excluded).

Register Here

Thanks for registering to our training program. See you there!

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