Radiation Sterilization for Medical Devices, offered by the Association for the Advancement of Medical Instrumentation (AAMI), covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices.
The course, to be held Oct. 2-5, 2012 at the Ritz-Carlton Denver, examines:
- FDA expectations regarding successful submissions and inspections, recalls, problem solving, and risk avoidance
- Scientific theory and principles of radiation sterilization
- The new global ANSI/AAMI/ISO 11137 series on radiation sterilization standards
- Integration of industry standards with the Quality System regulation
- Sterility Assurance Levels (SALs)
- Auditing processes for contract laboratories and sterilizers
- Radiation sterilization processing, including safety precautions, characteristics, constraints, and impact of radiation operations
This course is designed to be highly interactive between faculty and participants and will include relevant real life examples and “hands-on” exercises from a broad spectrum of medical device products.
The schedule is as follows:
— Overview of ANSI/AAMI/ISO 11137-1
— Microbiological Quality Tests
— Contract Sterilizers and Laboratories
— Sterility Assurance Levels
— Process Definition — Maximum Acceptable Dose
— FDA Perspective — PMA Submissions and Annual Reports
— Process Definitions — Sterilization Dose; Sterilization Dose: Method 1; and Sterilization Dose: Method VDmax
— FDA Perspective — Sterilization Questions
— Sterilization Equipment Validation
— Gamma Radiation — Processing and Validation
— Electron Beam and X-Ray Radiation — Processing and Validation
— Routine Processing
— FDA Perspective — Sterilization Inspectional Observations
— Process Definition — Sterilization Dose: Method 2
— Maintenance of Validation
— Changing Radiation Sterilization and/or Manufacturing Sites
— FDA Perspective — Future Concerns
This course is for professionals currently working in or with sterilization processes, particularly related to radiation sterilization. This includes design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams. For participants to gain the maximum benefit from this course, it is recommended they have a working knowledge of general sterilization principles.
In consultation with industry, government leaders, and educational experts, this course was developed to meet the medical device industry’s need for a better understanding of radiation sterilization principles, standards, and methods. The course will be taught by a mix of independent experts and industry representatives experienced in radiation sterilization. Instructors will provide a balanced presentation of radiation sterilization principles and practices as described in topics above.
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.