Industrial Sterilization for Medical Devices
Industrial Sterilization for Medical Devices is a comprehensive 4 day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more.
Course Objectives:
Course participants will learn how to:
- Apply the principles of sterilization
- Address sterilization requirements during product design
- Select and implement an appropriate sterilization process
- Identify the elements of successful sterilization validation
- Describe the critical parameters of a chosen sterilization process
- Participate in the design of process validation for moist heat, ethylene oxide (EO), and radiation sterilization processes
- Compare and contrast sterilization cycle developments based on product bioburden and those based on combined bioburden/overkill methods
- Correlate appropriate standards with sterilization processes and identify requirements pertinent to validation, packaging, and routine process control
- Describe the critical factors in making product release decisions
- Identify resources for complying with FDA requirements
Format
This highly interactive program combines classroom lecture with situational analyses that provide participants with the opportunity to apply what they learn to actual sterilization scenarios. In addition, participants will work through a series of case studies illustrating problematic situations. Case studies will cover various aspects and phases of sterilization processes...from design, to cycle development, to validation, to process control, to product release.
Program At-A-Glance
| DAY
ONE 8:00 AM-5:00 PM |
— Microbes and Sterilization — Validation — Test Method Validation — Microbial Lethality (D-Values and SALs) |
| DAY
TWO 8:00 AM-5:00 PM |
— Sterile Packaging — Radiation Sterilization — Introduction — Radiation Sterilization — Process Definition and Dose Establishment — Radiation Sterilization — Product Definition, Validation, and Routine Processing |
| DAY
THREE 8:00 AM-5:00 PM |
— Moist Heat and Ethylene Oxide — Moist Heat Sterilization — Introduction — Moist Heat Sterilization — Process Definition — Moist Heat Sterilization — Routine Processing |
| DAY
FOUR 8:00 AM-5:00 PM |
— Ethylene Oxide Sterilization — Introduction — Ethylene Oxide Sterilization — Process Definition — Ethylene Oxide Sterilization — Routine Processing — Contract Sterilizers and Laboratories — FDA Perspectives |
Course
Materials
As part of the course materials, attendees receive copies of standards on the validation and routine control for industrial moist heat sterilization, ethylene oxide sterilization, and radiation sterilization as well as standards and a technical information report on packaging for terminally sterilized devices.
Who Should Attend?
This program is recommended for professionals relatively new to the sterilization process environment who need information to help them better understand the principles and science of sterilization. This course is designed for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, or others directly involved in sterilization processes and responsible for meeting industry standards and FDA requirements.
Dates and Hotels
| DATES | LOCATION | PHONE & RATES |
| May 7-10, 2013 FULL |
The Marquette Hotel 710 Marquette Avenue Minneapolis, MN 55402-2368 Website |
800-328-4782 $179 single/double Rate through: 4/13/2013 |
| NOTE: Reservation requests 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. | ||
Faculty
In consultation with industry and government leaders, this course was developed to meet the medical device industry's need for a better understanding of sterilization principles, standards, and regulations. The mix of industry leaders, independent experts, and FDA personnel helps to ensure a balanced presentation of many aspects of industrial sterilization as described in the objectives.
Fee and Registration
Fee includes PowerPoint 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.
| REGISTRATION TYPE | FEES |
| AAMI corporate and institutional members | $2135 |
| AAMI individual members | $2235 |
| Nonmembers | $2635 |
| Government employees | $835 |