Registration Radiation Sterilization for Medical Devices
This 3½ day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. The course 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
Format
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.
| DATES | LOCATION | PHONE & RATES |
| October 2-5, 2012 | The Ritz-Carlton Denver |
303-312-3800 $204 single/double rate through 9/10/2012 |
| NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline. | ||
Program At-A-Glance
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Who Should Attend
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.
Faculty
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.
Course Materials
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.
Fee and Registration
Fee includsPowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.
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