Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Referierende
Luigi Scaffidi
Boehringer Ingelheim Pharma
Dr Björn Wiese
Janssen Pharmaceuticals
Michael Grosser
Lonza Biologics
Dr Florian Witte
Boehringer Ingelheim
Margarete Witt-Mäckel
Witt-Hygienemanagement
Exercises / Case Studies on:
Entering the Clean Area | Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology | Design of a Media Fill | Risk-based Determination of Interventions | Managing Deviations
Entering the Clean Area | Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology | Design of a Media Fill | Risk-based Determination of Interventions | Managing Deviations
Zielgruppe
GMP for Beginners in Sterile Manufacturing
The Online Training is directed to the following staff from the healthcare industry:
- Employees with little or no experience in current GMP requirements for sterile manufacturing
- Newcomers entering the pharmaceutical industry after vocational or academic Training
- Experienced professionals working in sterile manufacturing areas for the first time
- Suppliers who need to understand and meet the GMP and quality expectations of their pharmaceutical customers
Process Simulation / Media Fills
This education course is intended for staff from:
- Production,
- Quality Assurance,
- Microbiological Quality Control,
who are responsible for the planning and evaluation of aseptic process simulation (media fill) programmes.
The course is also valuable for decision-makers who must assess process simulation data in the context of batch release and aseptic process Validation.
The course is also valuable for decision-makers who must assess process simulation data in the context of batch release and aseptic process Validation.
Zielsetzung
GMP for Beginners in Sterile Manufacturing
Understanding and applying GMP regulations is fundamental to the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, employees have to comply with extensive requirements. Against this background, employees have to know the GMP requirements and must know how to use them in practice.
The question is: How can employees implement in their daily work regulations which are usually formulated in a very general manner?
Against this background, the Online Training has been designed for personnel working in sterile manufacturing who wish to build or strengthen their basic GMP knowledge. It introduces the most important pharmaceutical regulations governing sterile production and explains their relevance in everyday operations. Participants receive a structured overview of general GMP principles, as well as the specific requirements applicable to sterile manufacturing. The course also familiarises participants with the key processes in sterile pharmaceutical production.
To support the practical application of theory in everyday work, the training addresses common situations that employees encounter, such as correct cleaning and disinfection procedures, appropriate behaviour in clean rooms, entering clean room areas, environmental monitoring activities, and performing media fills.
The overall aim of the Online Training is to enable participants to understand regulatory expectations and to implement them confidently and pragmatically in their daily work in sterile manufacturing Environments.
Understanding and applying GMP regulations is fundamental to the manufacture of medicinal products and medical devices. Particularly in the manufacture of sterile medicinal products, employees have to comply with extensive requirements. Against this background, employees have to know the GMP requirements and must know how to use them in practice.
The question is: How can employees implement in their daily work regulations which are usually formulated in a very general manner?
Against this background, the Online Training has been designed for personnel working in sterile manufacturing who wish to build or strengthen their basic GMP knowledge. It introduces the most important pharmaceutical regulations governing sterile production and explains their relevance in everyday operations. Participants receive a structured overview of general GMP principles, as well as the specific requirements applicable to sterile manufacturing. The course also familiarises participants with the key processes in sterile pharmaceutical production.
To support the practical application of theory in everyday work, the training addresses common situations that employees encounter, such as correct cleaning and disinfection procedures, appropriate behaviour in clean rooms, entering clean room areas, environmental monitoring activities, and performing media fills.
The overall aim of the Online Training is to enable participants to understand regulatory expectations and to implement them confidently and pragmatically in their daily work in sterile manufacturing Environments.
Process Simulation / Media Fills
During this course, you will learn through 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 appropriate follow-up measures, and
- how Quality Assurance (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
GMP for Beginners in Sterile Manufacturing
Introduction – What is Specific for Sterile Manufacturing?
- What does sterile actually mean?
- Controlling raw material supply
- Sterilisation
- Sterile Manufacturing Facilities
- Process simulations
- Microbiological control
Regulations for Sterile Manufacturing
- Overview of regulation hierarchy
- Regulations on Aseptic Processing
- Applicable ISO Standards
Contamination Control Strategy (CCS)
- Objective
- Strategic and risk-based approach
- Effectiveness review and verification of measures
Microbiological Fundamentals
- Characteristics of microorganisms
- Microbial growth
- Microbial identification techniques
- Detection methods and their limitations
Clean Rooms and Barrier Systems
- Differences in the technology
- Decontamination vs. disinfection
- Validation aspects
- Environmental monitoring
- Risk considerations
Specific Training Requirements for Sterile Manufacturing
- Basics of microbiology
- Contamination sources and -transfer
- Clean rooms
- Hygienic behaviour
Cleaning and Disinfection
- Objectives, terms and definitions
- Types of detergents and disinfectants
- Application (procedures and methods)
- Toxicology (risk assessment, acceptance)
- Microbiological efficacy and qualification of disinfectants
- Influences on effectiveness (e.g. surface material, surface wetting)
- Validation of cleaning and disinfection procedures
Hygiene
- General definition, tasks and areas of application
- Purpose and function to pharmaceutical manufacturing
- Cleanroom and airlock concept, transfer procedures
- Personnel hygiene (gowning concept and gowning procedures, hygienic/aseptic behaviour)
- Operational hygiene (avoidance of cross-contamination, decontamination procedures)
Case Study: Entering the Clean Area
- Entering the clean area is a very critical step. Therefore, the gowning procedures must be validated and only personnel who have passed the gowning qualification are allowed to enter the clean area
- Attendees will be introduced to a new overall design combined with a new gowning technique that facilitates the aseptic gowning process
Sterilisation Processes
- Controlling bioburden / pyroburden
- Autoclaving
- Filtration
- Dry heat
- Gamma irradiation
- Ethylene Oxide
Involvement of the Microbiological Lab
- Counting micro-organisms
- Identifying micro-organisms
- Process validation
- Validating the sterility test
- Raw material testing strategy
- Trouble shooting
Environmental Monitoring
- Regulatory requirements
- Content and establishing of an environmental monitoring program
- Requirements concerning media and media suppliers
- Documentation and trending
Aseptic Process Simulation (APS)
- Regulatory requirements
- Microbiological media types
- Process simulation contamination
- Sample incubation
- Laboratory work
- Formal Report
Handling failures in Sterile Manufacturing
- Historical background
- Regulatory requirements
- Example for a non-conformity system
- Case studies
Case Studies „Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology“
Some practical examples from a pharmaceutical company will be demonstrated and discussed with the attendees.
Some practical examples from a pharmaceutical company will be demonstrated and discussed with the attendees.
Inspections / Audits / Observations
- Preparing for a formal inspection
- Managing an FDA audit of sterile manufacturing
- Internal audit program
- Real world observations
- Your OOS and OOT process
Aseptic Process Simulation (APS) / Media Fills
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
Managing Deviations - Root Cause Analysis
- Consequences of deviations in Media Fill
- Retrospective and prospective evaluation
- Relevant parameters in root cause analysis
Case Study: Managing Interventions
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)
GMP for Beginners in Sterile Manufacturing
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
Aseptic Process Simulation
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
*A discount of €500 applies when booking both courses together.*
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
GMP for Beginners in Sterile Manufacturing
Tue, 17 Nov 2026, 9:00 – 17.30 h
Wed, 18 Nov 2026, 9:00 – 17:30 h
Aseptic Process Simulation (APS)
Tue, 17 Nov 2026, 9:00 – 17.30 h
Wed, 18 Nov 2026, 9:00 – 17:30 h
Aseptic Process Simulation (APS)
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*: | € 3280,- |
| Non ECA Member*: | € 3680,- |
| EU/GMP Inspectorates*: | € 1590,- |
| APIC Member Discount*: | € 3480,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Sterile Production Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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