📄 ISO 11607 — Packaging for Terminally Sterilized Medical Devices — Certification Brochure
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IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 11607 — Packaging for Terminally Sterilized Medical Devices
REF: HL-EQP-11607
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Project Management for Packaging 0 chapters · 75 marks
2 Risk Management in Packaging 0 chapters · 75 marks
3 Quality Assurance Practices 0 chapters · 75 marks
4 Materials Science in Packaging 0 chapters · 75 marks
5 Packaging Design Principles 5 chapters · 100 marks
Fundamentals of Packaging Design for Medical Devices
Materials Selection for Sterile Packaging
Design Considerations for Sterilization Methods
Testing and Validation of Packaging Systems
Compliance and Quality Control in Packaging Design
6 ISO 11607 Regulations 5 chapters · 100 marks
Fundamentals of ISO 11607: Understanding Regulatory Frameworks
Packaging Design Requirements for Terminally Sterilized Medical Devices
Validation of Packaging Processes for Sterility Assurance
Risk Management in Packaging for Terminally Sterilized Devices
Quality Control and Assurance in ISO 11607 Compliance
Assessment Breakdown

Passing Mark: 325 / 500 (65%)

How to Enrol

Website: lapt.org

Email: info@lapt.org

Phone: +44 7513 283044

Address: 85 Great Portland Street, W1W 7LT, United Kingdom

Hours: Monday – Friday, 9AM – 5PM

LAPT — London Academy of Professional Training
Master Certificate | Leadership | Level 6-7
Ref: HL-EQP-11607
lapt.org
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ISO 11607 — Packaging for Terminally Sterilized Medical Devices