Course Name
Sterile Barrier System Validation: Awareness Training in ISO 11607-1 and ISO 11607-2
Course Overview
Welcome to the Sterile Barrier System Validation: ISO 11607-1 and ISO 11607-2 Training offered by ARG Academy. This 14-hour awareness program provides participants with a structured understanding of sterile barrier system requirements and packaging process validation for sterile medical devices.
The course introduces the core principles of ISO 11607-1 and ISO 11607-2, explains representative sterile barrier packaging systems, and reviews essential packaging verification methods. It comprehensively covers the fundamentals of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for packaging processes. Furthermore, the program highlights practical implementation considerations, including seal integrity, seal strength, transport testing, stability and ageing evaluation, documentation, routine monitoring, and change assessment.
Course Objective
The primary objective of this course is to build participant awareness and practical understanding of the requirements, verification expectations, and process validation principles applicable to sterile barrier systems used for terminally sterilized medical devices.
Course Benefits
By the end of this training, participants will be able to:
● Understand Barrier Systems: Grasp the regulatory purpose of sterile packaging for medical devices.
● Master ISO 11607: Navigate the core requirements of ISO 11607-1 and ISO 11607-2.
● Identify Packaging Types: Select appropriate applications for pouches, form-fill-seal, and reusable containers.
● Execute Verification: Conduct seal strength, dye penetration, transport, and stability testing.
● Validate Processes: Apply IQ, OQ, and PQ principles to packaging validation.
● Maintain Compliance: Manage required documentation, routine monitoring, and change controls.
● Apply Practical Skills: Drive internal compliance, audit preparation, and supplier communication.
Who Must Attend
This training is designed for professionals involved in sterile medical device packaging, sealing, validation, or release activities. Target participants include:
● Quality assurance and regulatory affairs personnel.
● Packaging, validation, and manufacturing engineers.
● Production supervisors and R&D personnel.
● Internal auditors and technical specialists.
Note: Participants are recommended to have basic knowledge of medical device manufacturing or quality systems; however, prior detailed knowledge of ISO 11607 is not mandatory.
Methodology
The course is delivered via face-to-face, instructor-led classroom training designed to maximize engagement and practical understanding. The delivery approach incorporates:
● Interactive lectures and clause-based explanations of the standards.
● Guided discussions and practical examples drawn from real-world scenarios.
● A dedicated workshop on sterile barrier packaging systems, allowing participants to review examples, identify potential nonconformities, and discuss suitable verification considerations.
● Question-and-answer sessions to clarify implementation issues.
● Participant understanding is evaluated through trainer questioning, workshop participation, and an end-of-program training effectiveness/knowledge assessment.
Course Duration
● Total Duration: 14 Hours (2 Days).
● Daily Schedule: Sessions run from 09:00 to 17:00, which includes designated time for participant registration, tea breaks, and lunch.
Frequently Asked Questions (FAQ)
What does the ISO 11607 standard cover?
The ISO 11607 standard specifies the rigorous requirements and test methods for materials, sterile barrier systems, and packaging systems. It is designed to ensure that terminally sterilized medical devices remain safe and sterile from the point of manufacturing until the point of use.
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 11607-1 and ISO 11607-2 Training training slot today and empower your QA team. Click the Enquiry button below to reserve your seats now.
