Course Objectives
At the end of the program participants should:
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Understand the philosophy and principles of sterilization.
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Aware of validation and routine control of the gamma radiation sterilization method and requirement.
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Understand key factors for sterilization process development.
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Understands validation, process control, and documentation of gamma sterilization.
Course Outline
UNIT 1: Set the State - Overview
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Recognizing and identifying sterile product
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Objectives of the workshop
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Agenda
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Administrative arrangement
UNIT 2: Overview of Sterilization
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Introduction
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Validation
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Process control & releasing.
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UNIT 3: Key Factor of Sterilization Process Development
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Contamination control
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Microbiological testing
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Maintaining sterilization effectiveness
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Target Audience
Quality Personnel, QA/QC Lab technician, and QA/QC Executive
Duration
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2 full-day courses
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Physical Training (On-site).
Advancement trough training
We provide:
Diverse learning methods:​
classroom-based, virtual, and blended courses
Industry-specific solutions:
tailored training for medical device manufacturers and sterilizers
Customized learning:
bespoke training solutions based on industry needs
Standard-based training:
comprehensive ISO and other standard-specific courses
Specialized subject training:
covering microbiology techniques and validation of test methods
Industry-experienced trainers:
expert trainers with years of experience in the industry
ISO 11137 Training
​Sterilization of Healthcare Products
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Philosophy and principles of sterilization.
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Validation and routine control method and requirement.
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Key factors for sterilization process development.
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Validation, process control, and documentation