Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.This two day highly interactive course will cover all aspects of radiation sterilization validation, materials selection and processing implementation. This workshop has been designed to help attendees learn the ins and outs of all the radiation modalities, materials selection, and validation of the sterilization process per ISO 11137.
Additionally, 483 case studies will explore how to avoid the operational and legal issues that arise from nonconformance with regulators (FDA) and auditors.
Learning Objectives:
Upon completing this course on radiation sterilization, participants will:
- Understand how to select product polymer materials for optimal product performance after radiation sterilization processing.
- Know how to complete an optimal validation test design - inclusive of dose, dosimetry, sample size, accelerated ageing, ASTM standards, and thermal analysis.
- Understand the effect of product design and assembly on bioburden, product safety and the success in executing the validation journey.
- Understand all the foundations of a successful radiation sterilization program - materials, bioburden, validation, maintenance of validation.
- Understand the impacts of all regulatory guidances on the radiation sterilization process.
- Perform risk assessments effectively.
- Understand where companies miss the mark in triggering, investigating and executing bioburden action levels and quarterly sterilization audits.
Who will Benefit:
This course is designed for medical device, biologic products, and pharmaceutical professionals who desire to get a complete understanding of the validation and use of radiation sterilization for their products. Following personnel will benefit from the course:
- Senior quality managers
- Sterilization managers
- Quality professionals
- Regulatory and Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- R&D engineers
- Process owners
- Quality engineers
- Quality auditors
- Medical affairs
- Legal professionals
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive - Here's a sneak peek:
Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation - the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Martin Byrne, Sterilization Consultant, Sterilization Illustrated
Martin Byrne has over 25 years of experience in the areas of radiation, ethylene oxide, and radiation sterilization including both gamma and ebeam sterilization. He has provided sterilization support for both large, mature medical device manufacturers as well as small startup companies. Currently, he owns Sterilization Illustrated a consulting and training business that provides support in the area of sterilization, microbiology, and controlled environments. An introductory video can be found at his website, www.sterilizationillustrated.weebly.com that will provide further information about Martin.
Please fill in your name and email to receive the Training Program of this event.
Time: 9:00 AM to 5:00 PM EDT
Venue
The venue is not yet available for this event.
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