Course Name
Validation, Routine Control, and Maintaining the Effectiveness of Radiation Sterilization ISO 11137 Training and Ethylene Oxide Sterilization ISO 11135 (2 Days)
Course Overview
Welcome to the Validation, Routine Control, and Maintaining the Effectiveness of Radiation Sterilization Training and Ethylene Oxide Sterilization program developed by ARG Academy. This two-day program provides practical, comprehensive guidance to help organizations plan, execute, and sustain compliant sterilization validation and routine control for both radiation and ethylene oxide (EO) terminal sterilization technologies. The content is strictly aligned with the key requirements and intent of ISO 11137 (Parts 1, 2, and 3) and ISO 11135:2014. The course emphasizes establishing a validated process, implementing effective routine monitoring, and maintaining ongoing effectiveness through robust change control and lifecycle management.
Course Objective
By the end of this Ethylene Oxide Sterelization & Radiation Sterilization Training, participants will be fully equipped to:
● Integrate Frameworks: Seamlessly align ISO 11137 and ISO 11135 with ISO 13485 QMS.
● Define Configurations: Establish product families and worst-case validation rationales.
● Select Validation Methods: Justify risk-based approaches (Method 1, VDmax, Method 2, and EO).
● Design Qualifications: Build robust IQ, OQ, and PQ strategies with clear acceptance criteria.
● Establish Routine Controls: Manage process monitoring, alert limits, and release decisions.
● Maintain Effectiveness: Implement change controls, revalidation triggers, and bioburden reviews.
● Prepare for Audits: Compile audit-ready protocols, reports, and objective compliance evidence.
Course Benefits
Participating in this Ethylene Oxide Sterelization & Radiation Sterilization Training offers strategic advantages and actionable tools for your sterilization operations:
● Hands-on Application: Participants engage in targeted group workshops to build practical outputs, such as validation plan outlines, routine control plans, and requalification decision trees tailored to their site.
● Deviation Management: Teams learn structured approaches to handle complex deviations, such as dose excursions, biological indicator (BI) positives, and out-of-spec lab results.
● Audit Readiness: The course trains participants to assemble complete, audit-ready validation packages with proper raw data traceability and conclusion logic.
● Practical Toolkit: Attendees receive valuable templates and checklists such as the Sterilization Effectiveness Annual Review Checklist that can be adapted directly into their facility’s procedures.
Who Must Attend
This training is specifically designed for professionals responsible for the development, control, and oversight of sterilization processes, including:
● Sterilization engineers and technical experts-in-training.
● QA/RA (Quality Assurance / Regulatory Affairs) and validation personnel.
● Auditors and sterilization service providers.
Note: It is highly recommended that participants possess a basic awareness of microbiology and Quality Management Systems (QMS) prior to attending.
Methodology
The course employs a highly interactive methodology to ensure that regulatory concepts are translated into practical workplace skills:
● Instructor-Led Training: Features detailed explanations of the ISO frameworks supported by standard-aligned examples.
● Group Workshops: Collaborative sessions where participants draft real-world documents, such as validation plans, acceptance criteria, and decision trees.
● Case Studies: Utilizes realistic scenarios requiring participants to perform impact assessments for deviations and facility changes (e.g., software upgrades or sensor replacements).
● Knowledge Checks: Competency is measured through short end-of-module quizzes, group presentations of workshop outputs, and an optional final assessment.
Course Duration
● Total Duration: 2 Days (approximately 14 training hours).
● Delivery Format: Available via Classroom or Virtual delivery, incorporating interactive breakout exercises.
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 training slot today and empower your QA team. Click the Enquiry button below to reserve your seats now.
