Validating Radiation Sterilization for Medical Products 2016

Key Topics

• Sterilization validation and Bioburden
• Materials Guidances - AAMI TIR # 17, ASTM
• Test Design
• Shelf Life Test Methods - Accelerated Aging design
• The influences of product assembly (molding, automation, etc.)`
• Product Design
• Regulatory Guidances - AAMI/ISO 11137, TIR #17
• Material selection and post irradiation degradation
• Biological Polymers - Tissue, Serum
• Packaging Design and Materials

Who should Attend

• Sterilization Experts
• Medical product design Management and Engineers
• Regulatory Affairs
• Quality Management and Engineers
• Purchasing and Supply Chain Managers
• Project Managers
• R&D Staff - engineering and lab personnel
• Staff evaluating risk, safety, and effectiveness
• Packaging Engineers
• Process Engineers
• Manufacturing Engineers
• Materials Engineers