Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Referierende
Luigi Scaffidi
Boehringer Ingelheim Pharma
Dr Florian Witte
Boehringer Ingelheim
A discount of €500 applies when booking this course together with the course "GMP for Beginners in Sterile Manufacturing".
Exercises / Case Studies on: Design of a Media Fill | Risk-Based Determination of Interventions | Managing Deviations
Exercises / Case Studies on: Design of a Media Fill | Risk-Based Determination of Interventions | Managing Deviations
Zielgruppe
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.
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.
Zielsetzung
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?
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?
Programm
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
Weitere Informationen
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.
Datum & Uhrzeiten
Thu, 19 Nov 2026, 9:00 – 17:30 h
Fri, 20 Nov 2026, 9:00 – 15:30 h
Fri, 20 Nov 2026, 9:00 – 15:30 h
All times mentioned are CET
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
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E-Mail: info@concept-heidelberg.de
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