This presentation is the third of three presentations on the methodologies for the determiniation of the minimum sterilization dose.
The new version of ISO/EN 11137-2:2006 has been approved and will be published mid-year 2006. This standard includes three methods for determination of the minimum sterilization dose.This presentation will review the steps for conducting Method VDmax and identifying typical issues that might arise when conducting the test method.
The new version of ISO/EN 11137-2:2006 has been approved and will be published mid-year 2006. This standard includes three methods for determination of the minimum sterilization dose.This presentation will review the steps for conducting Method VDmax and identifying typical issues that might arise when conducting the test method.
Areas Covered in the seminar:
Dose setting Method VDmax from ISO/EN 11137:2006, 'Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose’- The basis for the method
- The procedureal steps for conducting the method
- Updates based upon new the ISO/EN document
- Tpical issues that might arise
Who Will Benefit:
This webinar will provide valuable assistance to all regulated healthcare manufacturers that are using radiation sterilization to sterilize their products. The employees who will benefit will include individuals in the following areas:- Quality Assurance
- Sterility Assurance
- Validation
- Auditors
- Manufacturing and Operations
- Research and Development
Course Provider
Joyce Hansen,