MMD-107    ETO Validation Process

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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The use of ETO sterilization process has been worldwide accepted for more many years. The process has proof of it compatibility to many of disposable plastic medical devices with very minimum potential of risk.
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The ETO Validation processes shall need to be in accordance to the ISO 11135 guidance standard for ETO validation processes.

This course provides learners with:-

• Understanding of Process Validation requirements
• Understanding the methodology of validation processes
• Understanding the reference documents
• Identification of validation report

• Process Validation, definition and current approaches
• Important of Validation in Technical Documentation requirement
• Understanding risk assessment as part of process validation
• Understanding the ISO 11135 standard for ETO validation
• Pre-requirement prior for ETO Validation
• Biological Indicator and PCD preparation
• Validation methodology: IQ/OQ/PQ
• Validation documentation and support
• Post Validation requirement

• Managers
• QC trainers
• Who will be assuming the role of TQM facilitators

This is a 1-day programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.