Course Name
ISO 11137-1:2025 Transition, Technical Application & Radiation Sterilization Practical Training and Workshop (2 Days)
Course Overview
Welcome to the ISO 11137-1:2025 Transition, Technical Application & Radiation Sterilization Practical Training and Workshop offered by ARG Academy. This comprehensive, two-day practical program equips participants with the critical knowledge and skills necessary to successfully plan, validate, review, and maintain radiation sterilization processes specifically Gamma, Electron Beam, and X-ray.
A primary focus of this program is guiding organizations through a structured implementation and transition to the latest updated ISO 11137-1:2025 standard. Rather than relying solely on theory, the training incorporates guided group workshops utilizing realistic case scenarios and provided templates, ensuring that attendees leave with tangible, audit-ready outputs such as a process definition pack and a transition action plan.
Course Objective
By the end of this program, participants will be fully equipped to:
● Explain the core principles of radiation sterilization and distinguish the key differences between Gamma, Electron Beam, and X-ray processes.
● Interpret the ISO 11137 series requirements and map them directly to a compliant sterilization lifecycle and its associated documentation.
● Plan accurate dose mapping, define clear acceptance criteria, and establish dosimeter placement rationales alongside data review protocols.
● Apply practical, risk-based approaches for dose establishment and justification based on bioburden concepts.
● Construct a robust routine monitoring and control plan that includes dosimetry, dose audits, and batch review/release pathways.
● Evaluate process nonconformities (e.g., dose excursions, bioburden shifts, load changes) and confidently determine the appropriate corrective actions.
● Perform a structured gap assessment for the ISO 11137-1:2025 transition and develop a comprehensive implementation action plan.
Course Benefits
Participating in this workshop provides highly actionable advantages for your team and organizational compliance:
● Audit-Ready Deliverables: Participants actively produce functional outputs during the course, including a completed “Process Definition Pack” and a “Transition Gap Assessment & Action Plan” template.
● Comprehensive Toolkits: Attendees receive a workshop pack containing essential templates, such as process definition worksheets, dose mapping plans, routine monitoring and release checklists, and deviation investigation worksheets.
● Practical Validation Skills: Teams learn to handle real-world challenges, including underdose/overdose deviations, missing dosimeters, and abnormal mapping results.
● Certification: A Certificate of Attendance is issued to participants who complete the course activities and assessments.
Who Must Attend
This training is ideal for professionals operating within an ISO 13485 environment who are involved in the sterilization lifecycle. Basic QMS/validation awareness is beneficial, but advanced mathematics is not required. Target participants include:
● Sterilization and Validation Engineers and Specialists.
● QA/QC and Quality Management System personnel.
● Manufacturing and Process Engineers working with sterile products and packaging.
● Regulatory Affairs and Technical Documentation teams.
● Internal auditors and supplier auditors responsible for sterilization oversight.
● Sterilization service provider and contract sterilization personnel.
Methodology
The course is delivered using a dynamic, competency-based methodology that heavily emphasizes hands-on application:
● Instructor-Led Delivery: Interactive classroom lectures and facilitated discussions led by a Sterilization Technical Expert / Lead Auditor.
● Real-World Application: The curriculum utilizes case studies and scenarios viewed from both the manufacturer’s and the sterilization provider’s perspectives.
● Team-Based Workshops: Participants engage in collaborative workshops using provided templates to draft dose mapping plans, define grouping approaches, and perform gap assessments.
● Rigorous Assessment: Knowledge and competency are confirmed through a 10 to 15-question quiz and rubric-based evaluations of the workshop deliverables (assessing completeness, justification, and audit readiness).
Course Duration
● Total Duration: 2 Days (14 Training Hours).
● Daily Schedule: Sessions typically run from 09:00 to 17:00.
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