Registration 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.
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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.
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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.
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