IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 11737 — Sterilization of Medical Devices Microbiological Methods
REF: HL-BIO-11737
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Leadership and Team Management 5 chapters · 75 marks
Understanding Leadership Styles in Biotechnology
Building High-Performing Teams in the Sterilization Sector
Effective Communication and Conflict Resolution
Strategic Decision-Making for ISO Compliance
Leading Change in a Regulated Environment
2 Advanced Problem-Solving in Sterilization 5 chapters · 75 marks
Fundamentals of Sterilization Microbiology
ISO 11737 Standards and Compliance
Advanced Techniques in Sterilization Validation
Troubleshooting Common Sterilization Issues
Leadership Strategies in Sterilization Quality Assurance
3 Quality Management Systems in Biotechnology 5 chapters · 75 marks
Understanding Quality Management Systems in Biotechnology
ISO 11737 Standards and Their Application
Risk Management Principles in Sterilization Processes
Implementing and Sustaining an Effective QMS
Auditing and Compliance in Biotechnology Quality Systems
4 Testing and Validation Methods 5 chapters · 75 marks
Fundamentals of Sterilization in Medical Devices
Microbiological Testing Methods for Sterilization Validation
Designing Sterilization Validation Protocols
Interpreting and Reporting Sterilization Validation Results
Regulatory Compliance and Quality Assurance in Sterilization
5 ISO Standards and Compliance Requirements 5 chapters · 100 marks
Understanding ISO 11737 Standards and Principles
Microbiological Methods in Sterilization Practices
Regulatory Compliance and Quality Management Systems
Risk Assessment and Management in Sterilization Protocols
Implementing and Auditing Compliance to ISO 11737
6 Microbiological Principles of Sterilization 5 chapters · 100 marks
Fundamentals of Microbiology in Sterilization
Mechanisms of Sterilization Methods
Microbial Risk Assessment in Sterilization Processes
Validation of Sterilization Processes
Quality Control and Assurance in Sterilization
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

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ISO 11737 — Sterilization of Medical Devices Microbiological Methods