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 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 Radiation Sterilization Workshop program, participants will be fully equipped to:
● Master Radiation Principles: Distinguish between Gamma, E-Beam, and X-ray sterilization processes.
● Navigate ISO 11137: Map compliance requirements directly to your sterilization lifecycle and documentation.
● Plan Dose Mapping: Define acceptance criteria, dosimeter placement, and data review protocols.
● Establish Dosing: Apply risk-based dose justification using core bioburden concepts.
● Control Routine Monitoring: Manage dosimetry, dose audits, and safe batch releases.
● Resolve Nonconformities: Execute corrective actions for dose excursions, bioburden shifts, and load changes.
● Execute Gap Assessments: Build a comprehensive transition action plan for the ISO 11137-1:2025 update.
Course Benefits
Participating in this Radiation Sterilization 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 Radiation Sterilization Workshop 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 Radiation Sterilization Workshop 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.
HRD Corp Claimable Course
This is a 100% HRD Corp Claimable Training
Stop letting your monthly levy sit idle. Upgrade your workforce with our fully approved corporate training programs under the HRD Corp Claimable Course.
Why Choose ARG Academy?
● No Out-of-Pocket Cash: Fees are deducted directly from your e-TRiS account.
● Certified Trainers: All programs are led by HRD Corp TTT-approved experts.
● Zero Paperwork Hassle: We assist you with the entire grant application process.
● Flexible Programs: Tailored courses in Leadership, Digital Skills, Sales, and Soft Skills.
Secure Your Training Grant Today
Don’t let your training budget go to waste this year while regulatory requirements continue to tighten. Equip your team with the skills they need to ensure total medical device compliance. Book your corporate Radiation Sterilization Workshop slot today and empower your QA team. Click the Enquiry button below to reserve your seats now.
