GMP for Beginners in Sterile Manufacturing + Aseptic Process Simulation (APS) / Media Fills - Live Online Training
A discount of €500 applies when booking both courses together.
17-20 November 2026
Course No. 22595
Speakers
Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Luigi Scaffidi
Boehringer Ingelheim Pharma
Dr Björn Wiese
Johnson & Johnson
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
Target Group
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.
Objectives
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.
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?
Programme
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.
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
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) 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.
Date & Time
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)
Thu, 19 Nov 2026, 9:00 – 17:30 h Fri, 20 Nov 2026, 9:00 – 15:30 h
Testimonials
