Course Name
Irradiation Sterilization (Gamma, Electron Beam and X-ray) for Medical Device Manufacturers – ISO 11137 Compliance
Course Overview
Welcome to the Irradiation Sterilization (Gamma, Electron Beam and X-ray) for Medical Device Manufacturers training course, which focuses heavily on ISO 11137 Compliance. This comprehensive program walks participants through the critical stages of radiation science basics, regulatory considerations, and standard requirements for sterilized devices. The curriculum is structured to provide a logical progression:
● Day 1 covers the foundations, including an overview of irradiation sterilization (Gamma, EtO, steam, e-beam), ISO 11137-1 Validation and Routine Control, and integration with Quality Management Systems (QMS) like ISO 13485.
● Day 2 delves into advanced applications, including ISO 11137-2 Dose Setting Methods, ISO 11137-3 Routine Monitoring and Verification, ISO 11137-4 Practical Process Control, and managing nonconformities.
Course Objective
By the end of this training, participants will be able to achieve the following terminal and session objectives:
● Understand the ISO 11137 framework and apply it to medical device manufacturing, including a gap analysis of the latest revised ISO 11137-1:2025 standard.
● Execute and maintain sterilization validation (IQ, OQ, PQ) and routine monitoring programs specifically for Gamma, Electron Beam, and X-ray modalities.
● Integrate dose establishment, verification methods, and validation into overall production processes and the Quality Management System.
● Apply sterilization principles directly within the context of manufacturing controls.
● Address nonconformities effectively and ensure continuous process capability.
Course Benefits
Participating in this program offers valuable practical benefits and strategic advantages:
● Ensures that your organization maintains compliance with regulatory and customer expectations for sterile product manufacturing.
● Provides hands-on experience through a dedicated group exercise where participants draft a basic sterilization validation protocol using real product data.
● Helps teams learn when and how to accurately choose dose setting methods, such as Method 1, Method 2, VDmax25, and VDmax15.
● Equips staff to identify deviations, perform CAPA best practices for sterilization failures, and conduct impact assessments on released products.
● Provides robust training materials, including an ISO 11137 summary and interpretation guide, sample validation protocols, and templates.
Who Must Attend
This training is highly targeted for professionals responsible for sterile medical device manufacturing, including:
● Sterilization process engineers.
● QA/RA/QC personnel.
● Internal Auditors and technical experts.
● Manufacturing and production supervisors.
● Validation and process development teams.
Methodology
The course is delivered using a highly interactive and practical methodology designed to ensure knowledge retention:
● Expert Instruction: Features instructor-led sessions complete with interactive Q&A segments.
● Real-World Application: Utilizes case studies drawn directly from manufacturing environments and incidents.
● Hands-on Exercises: Incorporates group exercises using real or mock data to simulate workplace challenges.
● Visual Learning: Employs visual aids focusing on dose mapping, load patterns, and dosimetry.
● Assessment & Certification: Competency is evaluated through group activity participation and a final quiz/knowledge check, culminating in a Certificate of Completion upon successful participation.
Course Duration
● The standard course duration is 2 Days.
Note: This duration can be adjusted based on the required depth of the material and the chosen delivery method.
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