Exercises / Case Studies on: Design of a Media Fill | Risk-Based Determination of Interventions | Managing Deviations
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.
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, product quality usually cannot be ensured solely by laboratory testing of the final product. Process validation by means of media fills is therefore the only way to provide evidence of product safety. For this reason, media fills are rightly a major focus of regulatory requirements and official inspections.
A number of revised and harmonised international regulations—particularly 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 these requirements is critically assessed during official inspections.
In general, required media fills should be capable of simulating both routine operating conditions and worst-case scenarios. In practice, however, questions of feasibility often arise. How should these requirements be interpreted, and how can they be implemented, even for special production processes or dosage forms?
Programme
Current Regulatory Requirements and Expectations of an Inspector
EU-GMP Guide Annex 1
Regulatory changes through the new EU GMP Guide Annex 1
Contamination control
Inspection practice, questions
Design
Interventions
Visual inspection
Target, assessment
Media Fill observations
Requirements for Cleanroom Staff Qualification
Staff qualification
Staff disqualification
Training
Gowning qualification
Qualification with APS (success control)
Personnel monitoring
Design of Media Fill incl. Exercise
Overview PDA TR22
Parameter, which have to be consider in MF design
Different MF design alternatives
Consideration of long filling times
Consideration of holding times
The role of the MF in aseptic personnel qualification
Risk Management During Media Fill (Bracketing / Definition of Simulations / Interventions)
Approaches and parameters for bracketing concepts
Classification and grouping of interventions
Examples of simulations
Influence of the barrier system
Examples of risk management tools
QA-Oversight
Regulatory requirements
Different approaches to QA Oversight
Oversight during Media Fill execution
Link between Media Fill interventions and smoke studies
Exercise: Risk-based Determination of Interventions
Microbiological Investigations and Environmental Monitoring as Part of the Media Fill
EM and personnel monitoring during Media Fill
Responsibility for execution
Fertility testing of the growth medium
Incubation, Assessment and Evaluation
Important conditions for visual inspection
Personnel qualification
Evaluation methods for the Media Fill
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events 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.
Fees (per delegate plus VAT) ECA Members € 1,890 APIC Members € 1,990 Non-ECA Members € 2,090 EU GMP Inspectorates € 1,045 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Contacts Questions regarding content: Mr Clemens Mundo (Operations Director), +49 6221 84 44-42, mundo@concept-heidelberg.de Questions regarding organisation: Ms Nicole Bach (Organisation Manager), +49 6221 84 44-22, nicole.bach@concept-heidelberg.de.
Date & Time
Thu, 19 Nov 2026, 9:00 – 17:30 h Fri, 20 Nov 2026, 9:00 – 15:30 h
Testimonials
