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 Awareness Training – ISO 11607-1 and ISO 11607-2 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
Upon completion of this training, participants will be equipped to:
● Explain the purpose and regulatory relevance of sterile barrier systems for terminally sterilized medical devices.
● Describe key terms, concepts, and general requirements under ISO 11607-1 and ISO 11607-2.
● Identify common types of sterile barrier packaging systems (e.g., flexible peel pouches, form-fill-seal systems, reusable containers) and their intended applications.
● Describe key packaging verification activities, including visual inspection, seal strength testing, dye penetration, transport testing, and stability/ageing considerations.
● Explain the principles of packaging process validation, specifically focusing on IQ, OQ, and PQ.
● Recognize the required documentation, routine monitoring, and change control considerations necessary for maintaining compliant packaging systems.
● Apply the awareness gained to directly support internal compliance, supplier communication, audit preparation, and validation planning.
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.
HRD Corp Claimable Course
100% HRD Corp Claimable Training
Stop letting your monthly levy sit idle. Upgrade your workforce with our fully approved corporate training programs under the SBL-Khas Scheme.
Why Choose Us?
● 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. Slots fill up fast! Click the Enquiry button below!
