Course Objectives
At the end of the program participants should:
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Understand the philosophy and principles of sterile barrier systems and packaging systems.
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Awareness of validation and routine control of the sterile barrier systems and packaging systems method and requirement.
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Understand the key factors for sterilization process development.
Course Outline
UNIT 1: Overview
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Recognizing and identifying sterile product
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Administrative arrangement
UNIT 2: Overview of Sterile Barrier Systems and Packaging Systems
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Representative’s types of sterile barrier systems and packaging systems
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Packaging verification
UNIT 3: Key Factors of Sterile Barrier Systems and Packaging Systems Process Development
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Packaging process validation
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Awareness of ISO 11607-1 and ISO 11607-2
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); or
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Online Training
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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 11135:2014 Training
Sterilization of Healthcare Products - Ethylene Oxide
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Understand the philosophy and principles of sterile barrier systems and packaging systems.
-
Awareness of validation and routine control of the sterile barrier systems and packaging systems method and requirement.
-
Understand the key factors for sterilization process development.
