Aseptic Process Simulation (APS) / Media Fills - Live Online Training
20/21 November 2025
Course No. 21910
Speakers
Dr. Florian Witte
Boehringer Ingelheim
Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Luigi Scaffidi
Boehringer Ingelheim Pharma
Objectives
During this course you will learn in lectures and workshops
The new requirements of the revised EU Annex 1
How to plan a media fill in compliance with European and US GMP requirements,
How to interpret the results of a media fill,
How to investigate deviations and define follow-up measures and
How QA should be involved
Background
In the aseptic processing of medicinal products, the product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is the only way to furnish proof of product safety, which is why it justly is the focus of regulatory requirements and official inspections.
A number of revised and harmonised international regulations, especially the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“, the EU-GMP-Guide Annex 1, ISO 13408 and the PIC/S Guide „Recommendation on the Validation of Aseptic Processes“, define highly detailed requirements, the implementation of which is critically examined within the framework of official inspections.
In general, the required media fills should be able to simulate both routine operation and worst-case conditions. In practice, the question of practicability often arises. How should the requirements be interpreted and how can they be implemented even for special production processes or dosage forms?
Target Group
This Education course is directed at staff from
Production
Quality Assurance
Microbiological Quality Control
who are responsible for the planning and evaluation of Aseptic Process Simulation (Media fill) programmes.
It is also valuable for decision makers who have to deal with Process Simulation data within the framework of production release and Aseptic Process Validation.
Date & Technical Requirements
Date of the Live Online Training Thursday, 6 November 2025, 09.00 h – 17.30 h (CET) Friday, 7 November 2025, 09.00 h – 15.30 h (CET)
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/onlinetraining-technical-information you will find all the Information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a Standard nowadays and the necessary installation is fast and easy.
Testimonials
Seminar Programme as PDF