Course Name
Sterilization: Awareness Training in ISO 17665:2024
Course Overview
Welcome to the Sterilization: Awareness Training in ISO 17665:2024 Development, Validation & Routine Control offered by ARG Academy. This comprehensive course details the requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. The curriculum is strategically divided into two phases: Day 1 establishes the Foundation & Process Characterization, while Day 2 focuses on Validation, Routine Control, and Sustaining Effectiveness.
Course Objective
By the end of this training, participants will be able to:
● Explain the core purpose of sterilization, differentiate moist heat from other methods, and understand critical concepts such as the probability of survival and SAL 10^-6.
● Understand the scope and structure of ISO 17665:2024, including its Quality Management System (QMS) links to ISO 13485.
● Evaluate microbicidal effectiveness, assess material compatibility, and understand chamber design alongside key parameters (Temperature, Pressure, F0, and z-values).
● Define product families, load configurations, and reference load concepts.
● Describe IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) requirements, differentiating between physical and microbiological validation approaches.
● Establish ongoing process verification, routine monitoring, and strict product release criteria, including deviation handling and conditional releases.
● Understand the processes required for equipment requalification, calibration, preventive maintenance, and change management.
Course Benefits
Participating in this training provides significant practical advantages and actionable takeaways:
● Hands-on practice with critical cycle parameter calculations, including F0, z-value, and D-value.
● Exposure to real-world audit case studies focusing on sterilization validation and change control within industrial and health-care facility settings.
● Extensive reference materials provided to attendees, including extracts from Annex B & H of ISO 17665:2024, sample validation protocols, audit checklists, a process verification checklist, and a cleanroom behavior guide.
Who Must Attend
This course is explicitly targeted at professionals involved in medical device sterilization and compliance, including:
● QA/RA (Quality Assurance / Regulatory Affairs) personnel.
● Sterilization engineers.
● Validation specialists.
● Auditors.
● Regulatory assessors.
Methodology
The course utilizes a highly interactive and varied training format to ensure thorough comprehension and practical competency:
● Instructor-led Presentations: Detailed sessions covering the theoretical and regulatory aspects of the ISO 17665:2024 standard.
● Audit Case Studies & Workshops: Group exercises featuring real-world sterilization validation issues, PQ validation exercises, document reviews, and validation gap analyses.
● Visual Learning: Includes engaging video demonstrations of an operational sterilization plant.
● Assessments & Competency Checks: Participant knowledge is measured through a 10-question MCQ pre-test, a 10-question MCQ post-test, and an interactive group audit simulation activity.
● Certification: Successful completion of the program results in the issuance of a Certificate of Attendance or Competency.
Course Duration
● The training spans 2 Days, encompassing 14 hours of comprehensive, instructor-led instruction.
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