Quality is always the result of excellent work without compromise.
MMD-107 ETO Validation Process
Schedule and Hours
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. 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
Who will be assuming the role of TQM facilitators
This is a 1-day programme. 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.