Course Name
Validation, Routine Control, and Maintaining the Effectiveness of Radiation Sterilization (ISO 11137) and Ethylene Oxide Sterilization (ISO 11135) (2 Days)
Course Overview
Welcome to the Validation, Routine Control, and Maintaining the Effectiveness of Radiation Sterilization (ISO 11137) and Ethylene Oxide Sterilization (ISO 11135) training 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 course, participants will be fully equipped to:
● Explain the ISO 11137 and ISO 11135 process validation frameworks and how they integrate seamlessly with an ISO 13485 Quality Management System.
● Define product families, challenge/product configurations, and establish worst-case rationales for validation planning.
● Select and justify appropriate validation approaches based on risk and evidence, including Method 1, VDmax, and Method 2 for radiation, and product/family approaches for EO.
● Design a robust qualification strategy encompassing IQ, OQ, and PQ (including MPQ/PPQ where applicable), and define clear acceptance criteria.
● Establish routine control requirements, encompassing process monitoring, release decisions, alert/action limits, and periodic verification.
● Implement an effective ongoing effectiveness program that incorporates change control, revalidation triggers, bioburden/sterility assurance reviews, and trend analysis.
● Prepare audit-ready documentation packages, including protocols, reports, and objective evidence for conformity assessment.
Course Benefits
Participating in this program 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.
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