An intensive one-day course to establish and improve compliance with ISO 11135:2014.
Background
The course is designed to ensure delegates fully understand the new and revised requirements contained in ISO 11135: 2014, which is a major revision of the 2007 version of the standard. This standard addresses requirements for control and validation of ethylene oxide sterilization processes.
Learning Objectives
The course provides an excellent opportunity to:
- Understand the importance of compliance with the requirements to ensure that the Sterility Assurance Level (SAL) is achieved for medical devices.
- Understand the key steps in performing adequate validation in all stages of IQ, OQ and PQ.
- Understand the nature and types of Biological Indicators and their use in Internal and External PCDs
- Identify, plan and execute improvement to sterilization activities in a structured and efficient manner, to satisfactorily meet both business and regulatory responsibilities.
- Ensure your needs are properly addressed in subcontract sterilization facilities used to sterilize your medical devices.
Course Format
The course presents ISO 11135:2014 comprehensively, uses lectures, discussions and group exercises. Each delegate will be provided with a comprehensive course manual, and copies of relevant regulations, standards and guidance documents are provided for the use of delegates during the course.
Delegates will receive a "Certificate of Attendance".