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ISO 11607 Explained: Packaging for Terminally Sterilised Medical Devices
1 December 2026 | Short Online Course
Original price was: $467.$374Current price is: $374.
1-Day Live Online training | Learn how to design, validate, and manage packaging systems that comply with ISO 11607.
Learn more about the course by toggling through the tabs below.
Course Overview
Packaging plays a critical role in ensuring the sterility, integrity, and safety of medical devices throughout their lifecycle. ISO 11607-1 and ISO 11607-2 set the international standard for packaging system design, material selection, process validation, and ongoing control for terminally sterilised medical devices.
This concise and practical training course provides an in-depth overview of the requirements, expectations, and best practices for complying with ISO 11607. Participants will learn how to select suitable packaging materials, design compliant systems, validate sealing and assembly processes, and maintain packaging integrity through distribution and shelf life. Real-world examples will be used to demonstrate compliance with regulatory and audit requirements under MDR and FDA frameworks.
Key Learning Objectives
- Understand the structure and key requirements of ISO 11607-1 and ISO 11607-2.
- Apply the principles of packaging system design for terminally sterilised medical devices.
- Select appropriate materials and configurations compatible with sterilisation processes.
- Plan and conduct packaging process validation and routine monitoring.
- Establish robust documentation, traceability, and change control systems.
- Prepare for audits and demonstrate compliance with ISO 11607 to regulators and Notified Bodies.
Who Should Attend?
This course is suitable for professionals working across the medical device and combination product sectors, including:
- Quality Assurance and Regulatory Affairs professionals
- Packaging Engineers and Designers
- Manufacturing, Production, and Operations Managers
- Validation Engineers
- Internal Auditors
- Anyone responsible for packaging design, qualification, or compliance in a medical device QMS
Course Outline
Course Information
- The course begins at the time stated at the top of the page
- The course is broken up into modules outlined below
- There will be breaks between modules
1 December 2026
1-Day Live Online Training
Register at the top of the page.
Session 1
120 mins | 10:00 AM UK
Introduction to ISO 11607 and Its Regulatory Context
- Overview of ISO 11607-1 and ISO 11607-2
- Key definitions: sterile barrier system, packaging system, protective packaging
- Relationship between ISO 11607, MDR, and FDA requirements
- The importance of packaging in maintaining sterility assurance and product quality
Packaging System Design and Material Selection
- Principles of packaging system design for terminally sterilised devices
- Selecting materials based on device type, sterilisation method, and performance requirements
- Evaluating packaging compatibility with sterilisation processes (EtO, radiation, steam, etc.)
- Case examples of compliant packaging configurations
Session 2
120 mins | 10:00 AM UK
Validation and Control of Packaging Processes
- Validation requirements under ISO 11607-2: sealing, assembly, and packaging equipment qualification
- Routine monitoring and periodic revalidation
- Ensuring package integrity and sterility maintenance through transportation and storage
- Packaging process documentation and change control
Documentation, Traceability, and Audit Readiness
- Required documentation for packaging systems and validation
- Establishing traceability and linking design, validation, and production records
- Common audit findings and how to address non-conformities
- Demonstrating compliance during regulatory inspections
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Wrap-Up and Q&A
- Key takeaways and best practices for maintaining ISO 11607 compliance
- Open discussion and practical advice
Annette Callaghan is a quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Format, Dates & Times
Find out when this course is running so you can plan your training. Scroll down to view the full agenda.
1 December 2026
1-Day Live Online Training
Register at the top of the page.
Course Times
For live online delivery, the course starts at 10:00 AM (UK time) and finishes at 3:00 PM (UK time).
Group Discount
If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.
For a quote, complete our contact form by following the link. Get in touch.
Customised Team Training
We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.
For more information, complete our contact form by following the link. Get in touch.
What is Included?
Certification
Download your official Educo Life Sciences Certificate of Attendance to showcase your achievement and professional development.
Access to Recordings for 2 Weeks
Enjoy unlimited access to all session recordings for up to 2 weeks after the final session — perfect for revision or catching up.
Learner Reference Guide
Attendees receive an overview packed with key concepts, examples, and references from your training to support you long after the course concludes.
Live Online
This course is delivered live online with direct access to the trainer.
4 Hours of Learning
This course includes a total of 4 hours of learning.
Expert Trainer
Engage directly with leading trainers who bring real-world experience and insider knowledge to every session.
Additional Course Information
Free Online Module
Free Online Module
- Some of our courses include a free to attend module 1. Please check above to see if this applies to this course.
- If applicable, module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.
- To register for module 1, please submit your details in the form located above.
- Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
Full Course Information and Pricing
Full Course Information and Pricing
- To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
- There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
- The full training course is delivered either online or in a classroom. Please check which course format you have booked.
- For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.
- For live online courses – The dates and times of modules/sessions are subject to change.
- For live online courses – The module/session durations are approximate.
On-Demand Information and Pricing
On-Demand Information
- Most courses are available on-demand. If you select this option you will be able to begin training instantly.
- You will gain access to a previous live online session, slides and learner reference guide.
- You will also be added to the next live session, giving you the opportunity to attend and interact directly with the trainer if you wish.
- Depending on the course length you will have access to the on-demand materials for 1 to 3 months.
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