Public Training · HRD Corp Claimable & RegisteredISO 11135:2014 EO Sterilization Requirements Training
A two-day, face-to-face program on Ethylene Oxide sterilization of medical devices — for the people who design, validate, and release EO cycles and need to work from the standard itself, not a summary of it.
Reserve your seatSee the two-day program
Built for the people who own the sterilization process, not just the paperwork.
- QA/RA officers and sterilization engineers at medical device manufacturers and contract sterilizers
- Process owners responsible for EO cycle design, qualification, or routine release
- Internal auditors who need to audit sterilization records against ISO 11135:2014
- Anyone newly assigned EO sterilization compliance and starting from scratch
Clause-by-clause understanding of ISO 11135, grounded in real cycle data.
- A clause-by-clause working grasp of ISO 11135:2014, from QMS integration to risk management under ISO 14971
- Confidence running IQ, OQ, and PQ validation, and choosing between overkill and BI/bioburden approaches
- Working knowledge of EO/ECH/EG residual limits, biological indicators, SAL, and batch release criteria
- Hands-on practice through two group workshops, a 10-question post-test, and a certificate of completion
Abdul Rahman
Ab Ghani
Over 30 years of hands-on experience in medical device manufacturing and QMS — including 13 years progressing from Laboratory Technician to Head of Quality Assurance, and 11 years specialising in sterilization validation across Gamma Irradiation, Ethylene Oxide, and Moist Heat.
- ✓30+ years industry experience
- ✓13 years auditing ISO 11137, ISO 11135, ISO 17665, ISO 11737, ISO 13485
- ✓HRD Corp Accredited Trainer, valid to 2028
- ✓MIM Certified Train-the-Trainer, since 2012
Want the fuller picture? Learn more about ARG Academy’s story and accreditations on our About Us page.
Day one builds the standard. Day two puts it into practice.
A practitioner-led structure that moves from ISO 11135:2014’s requirements to the mechanics of qualifying and releasing an EO sterilization process.
7 modules + group workshop
- 01Introduction to EtO sterilization — methods, EtO characteristics, ISO 11135:2014 overview, key terms
- 02Structure of ISO 11135:2014 — clause-by-clause breakdown and key focus areas
- 03Roles & responsibilities — manufacturer vs. contract sterilizer, legal obligations, quality agreements
- 04QMS requirements — documentation control, ISO 13485 integration, change control & internal audit
- 05Risk management in EtO sterilization — ISO 14971 link, hazard identification, risk controls
- 06EtO process overview & sterilization cycle — preconditioning, sterilization, aeration, critical parameters
- 07Validation overview — IQ/OQ/PQ introduction, overkill vs. BI/bioburden, validation tools
- WSWorkshop — preparing a sterilization validation plan for a new product, with group presentation
7 modules + workshop + post-test
- 08Detailed validation protocols — IQ, OQ, PQ, load configuration & chamber studies
- 09Microbiological requirements — bioburden testing, biological indicators, SAL & statistical concepts
- 10EO residuals & biocompatibility — ISO 10993-7, EO/ECH/EG exposure limits, testing & acceptance criteria
- 11Routine process control & monitoring — control charts, batch release criteria, routine BI & EO sensor use
- 12Requalification & change control — triggers, managing process/product changes, maintaining a validated state
- 13Handling deviations, failures & nonconformities — investigations, CAPA, documentation for regulators
- 14Documentation & audit readiness — validation files, audit trail, preparing for MDA/FDA/NB inspections
- WSWorkshop — risk-based process validation, evaluating change control & requalification needs
- ✓Post-test and wrap-up — 10-question assessment, answer review, participant feedback
Secure your seat before the training fills up.
Fees cover both training days, a full participant manual, group case study worksheets, pre/post-test quiz, and a certificate of completion. HRD Corp claimable for eligible employers.
Standard rate
Seats confirmed on a first-come basis
- ✓ 2 full training days, face-to-face
- ✓ Course materials + certificate
- ✓ HRD Corp claimable
HRD Corp claimable — Course number 10001656857. ARG Academy PLT is also a HRD Corp Registered Training Provider. Check with your HR team on remaining levy balance before submitting your claim.
Fill in the form below and we’ll confirm your seat by email within one business day.
One classroom, two days, Rawang.
Common questions
Is this training HRD Corp claimable?
Yes. The program is registered under HRD Corp course number 10001656857. Confirm your levy balance and claim process with your HR or training coordinator before the session.
Do I need prior ISO 11135 knowledge to attend?
No. Day one is built to bring anyone up to speed on the standard itself before day two moves into validation records and audit practice, so first-timers and those refreshing their knowledge are both well served.
What does the training fee include?
Both training days at the Rawang venue, course materials, and a certificate of completion. Travel and accommodation are not included.
Can I register a group from my company?
Yes — list every participant’s name and designation when you email in, so certificates and HRD Corp claims can be prepared correctly for each attendee.
Talk to us before you register
Not ready to fill in the form yet? Reach out directly and we’ll help you decide if this training’s the right fit for your team.
Seats are limited to keep the workshop hands-on.
Competence Today. Compliance Tomorrow. Patient Safety Always.