Course Overview

Aseptic processing is critical to ensuring the microbiological safety and regulatory compliance of medical devices. The ISO 13408 series of standards defines the expectations for aseptic process design, validation, and control, while integration with ISO 14971 risk management principles ensures a robust, compliant quality system.

This course provides a practical overview of aseptic processing principles, validation strategies, and contamination-control techniques in alignment with global regulatory expectations, including EU MDR and FDA requirements. Participants will learn how to interpret ISO 13408 requirements, design compliant facilities and processes, conduct process simulations, and integrate risk-based decision making into aseptic operations.

Learn more about how we deliver live online training.

Key Learning Objectives

• Understand aseptic processing principles and their application to medical devices.
• Interpret and apply the ISO 13408 series to aseptic process design, validation, and control.
• Differentiate aseptic processing from terminal sterilisation and identify critical process parameters.
• Design facilities and cleanroom environments compliant with ISO 14644 standards.
• Plan, execute, and interpret aseptic process validation activities, including media fills and environmental monitoring.
• Integrate aseptic controls within a risk-based quality system (ISO 14971).
• Implement effective contamination-control strategies involving personnel, equipment, and environment.
• Maintain ongoing compliance with MDR, FDA, and Notified Body expectations.

Who Should Attend?

This course is ideal for professionals involved in aseptic manufacturing, validation, and compliance within the medical device and combination-product industries, including:

• Regulatory Affairs and Quality Assurance professionals
• Validation Engineers and Manufacturing Managers
• Design & Development Engineers
• Microbiologists and Sterility Assurance Specialists
• Risk Management and Compliance Personnel
• Quality System Auditors and Consultants

Format, Dates & Times

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

20 & 21 April 2026

7-Hour Course Delivered Over 2-Days
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Course Times

For live online delivery, both sessions start at 1:00 PM (UK time) and finish at 4:00/4:30 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.