Learn from two of the foremost validation, materials, and operations leaders in the marketplace. The course instructors have decades of experience in microbiology, validation, operations on traditional as well as tissue/biologic and combination products. Save time and money by attending this course dedicated to increasing your knowledge in radiation sterilization.
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.
- 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.