This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.
Areas Covered in the seminar :
- General requirements of ISO 11137:2006, Method 1 and VDmax25, to include (but not limited to):
- Pre-validation activities and requirements.
- Product bioburden testing and analysis.
- Laboratory methods and practices.
- Analysis of verification dose results.
- Basics components of protocol and final report.
Who Will Benefit :
- Validation engineers cross-training into ISO sterilizer validations
- Laboratory staff involved with validation activities
- Quality or Regulatory staff now being assigned sterilizer validation responsibilities
- Supervisors of Manufacturing or Laboratory Departments responsible for sterilization processes
- Auditors responsible for reviewing contract sterilizer documents or quarterly dose audit records
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