Day 4:
— Maintenance of validation
— Changing radiation sterilization and/or manufacturing sites
— FDA perspective — future concerns
Participants will receive the following:
• ANSI/AAMI/ISO 11137-1:2006(R)2010 Sterilization of health products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
• ANSI/AAMI/ISO 11137-2:2006 Sterilization of health products – Radiation – Part 2: Establishing the sterilization dose;
• ANSI/AAMI/ISO 11137-3:2006(R)2010 Sterilization of health products – Radiation – Part 3: Guidance on dosimetric aspects;
• Pertinent FDA documents; additional references; and a participant's guide for easy note-taking.
The cost is $1,935 for AAMI corporate and institutional members; $2,035 for AAMI individual members; $2,435 for non-members; and $635 for government employees.
To register, click here.
