Course Name
Sterilization: Awareness Training in ISO 17665:2024
Course Overview
Welcome to the ISO 17665 Sterilization Awareness Training 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 equipped to:
● Master Sterilization Concepts: Differentiate moist heat methods and apply survival probability principles (SAL 10⁻⁶).
● Navigate ISO 17665:2024: Seamlessly integrate the standard’s requirements with your ISO 13485 QMS.
● Evaluate Key Parameters: Assess microbicidal effectiveness, chamber design, F0, and z-values.
● Define Configurations: Establish accurate product families and reference loads.
● Execute IQ/OQ/PQ: Conduct robust physical and microbiological validation processes.
● Control Routine Operations: Manage strict product releases, process monitoring, and deviations.
● Maintain Equipment Compliance: Oversee calibration, requalification, and change management.
Course Benefits
Participating in this ISO 17665 Sterilization Awareness 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 ISO 17665 Sterilization Awareness Training 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 ISO 17665 Sterilization Awareness Training 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.
Frequently Asked Questions (FAQ)
What does the ISO 17665 standard cover?
ISO 17665 specifies the requirements for the development, validation, and routine control of a moist heat (steam) sterilization process for medical devices. It is a critical framework for ensuring that healthcare products are consistently safe and sterile.
Who should attend this sterilization awareness training?
This program is highly recommended for Quality Assurance (QA) personnel, medical device engineers, regulatory affairs officers, and production managers operating within the medical and healthcare manufacturing sectors.
HRD Corp Claimable Course
This is a 100% HRD Corp Claimable Training
Stop letting your monthly levy sit idle. Upgrade your workforce with our fully approved corporate training programs under the HRD Corp Claimable Course.
Why Choose ARG Academy?
● No Out-of-Pocket Cash: Fees are deducted directly from your e-TRiS account.
● Certified Trainers: All programs are led by HRD Corp TTT-approved experts.
● Zero Paperwork Hassle: We assist you with the entire grant application process.
● Flexible Programs: Tailored courses in Leadership, Digital Skills, Sales, and Soft Skills.
Secure Your Training Grant Today
Don’t let your training budget go to waste this year while regulatory requirements continue to tighten. Equip your team with the skills they need to ensure total medical device compliance. Book your corporate ISO 17665 Sterilization Awareness Training slot today and empower your QA team. Click the Enquiry button below to reserve your seats now.
