TRAINING COURSE CONTENT Training Provider ARG Academy PLT. Course Duration 14 Hours (2 Days) Training Mode Face-to-face / instructor-led classroom training Primary Reference ISO 11607-1 and ISO 11607-2 awareness, packaging verification, and packaging process validation 1. Course Overview Course Title Sterile Barrier System Validation Awareness Training – ISO 11607-1 and ISO 11607-2 Course Category […]
Read MoreCourse Title: Ethylene Oxide Sterilization of Medical Devices – ISO 11135:2014 Requirements Training Duration: 2 Days (14 Hours Total) Day 1: Foundational Understanding and Regulatory Requirements Module 1: Introduction to Ethylene Oxide Sterilization (1 hour) Introduction to sterilization methods Characteristics of EtO and why it’s used Overview of ISO 11135:2014 Key terms and definitions Module […]
Read MoreDocument Control Item Description Item Description Course Code RS-EO-VAL-2D Version 1.0 Duration 2 days (approx. 14 hours) Delivery Classroom / Virtual (with breakout exercises) Target Audience Sterilization engineers, QA/RA, validation personnel, auditors, service providers, technical experts-in-training Prerequisites Basic microbiology & QMS awareness recommended Reference Standards ISO 11137 series; ISO 11135:2014; ISO 11737 series; ISO 10993-7; […]
Read MoreTraining Objectives Understand ISO 14644-based cleanroom classifications and regulatory context. Identify sources of contamination and apply contamination control principles. Perform cleanroom gowning, hygiene, and behavioural protocols. Implement cleanroom monitoring, cleaning, documentation, and qualification. Assess risk, set up alert/action limits, and manage cleanroom compliance effectively. Training Duration 2 Days (8 hours/day including breaks) Target Audience QA […]
Read MoreObjectives: Aim to ensure compliance with regulatory requirements, maintain product safety, and minimize contamination risks. The key objectives are: To provide an overview of sterilization methods used for medical devices, with a focus on Ethylene Oxide (ETO) sterilization. To develop participants’ understanding of sterilization validation and routine control monitoring in compliance with ISO 11135. To introduce […]
Read MoreCourse Overview This programme provides structured competency development on Ethylene Oxide (EO) sterilization safety and environmental control for personnel involved in sterilization operations, engineering, EHS, quality assurance, regulatory compliance, and facility oversight within the medical device industry. The course focuses on safe EO gas handling, exposure prevention, engineering and administrative controls, monitoring systems, emergency preparedness, […]
Read More1. Programme Overview This 2-day practical programme equips participants with the knowledge and skills to plan, validate, review, and maintain radiation sterilization processes (Gamma, Electron Beam, and X-ray) and to implement a structured transition to ISO 11137-1:2025. The training includes guided group workshops using templates and realistic case scenarios to produce audit-ready outputs (process definition […]
Read MoreCourse Title: Irradiation Sterilization (Gamma, Electron Beam and X-ray) for Medical Device Manufacturers – ISO 11137 Compliance Target Audience Sterilization process engineers QA/RA/QC personnel Internal Auditors and technical experts Manufacturing and production supervisors Validation and process development teams Terminal Objectives By the end of this training, participants will be able to: Understand the ISO 11137 […]
Read MoreTraining Course Title: Radiation Sterilization: Technical Application, Guidance, and Transition to ISO 11137-1:2025 including AAMI/ISO TIR 11137-4:2022 and ISO/TS 11137-4:2020 (1 day) Target Audience: Sterilization Process Owners Quality Assurance/Regulatory Affairs Validation and Qualification Engineers Contract Sterilization Providers Auditors and Consultants Course Duration: 1 Full Day (7 hours) Training Objectives: Understand the purpose and structure of […]
Read MoreDuration: 2 Days (≈ 14 hours total) Target Participants: QA/RA personnel, sterilization engineers, validation specialists, auditors, and regulatory assessors Training Format: Instructor-led presentations + group exercises + case studies + quiz Reference: ISO 17665:2024 – Sterilization of health-care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process […]
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