Course Tag: Sterile Barrier System

Sterile Barrier System Validation: Awareness Training in ISO 11607-1 and ISO 11607-2

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 […]

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Comprehensive Training on ETO Sterilization and Compliance for Sterile Medical Device Manufacturing

Objectives:  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 […]

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