Dr Björn Wiese
Janssen Pharmaceuticals
Referierende
Michael Grosser
Lonza Biologics
Dr Florian Witte
Boehringer Ingelheim
Margarete Witt-Mäckel
Witt-Hygienemanagement
A discount of €500 applies when booking this course together with the course "Aseptic Process Simulation".
Incl. Case Studies: “Entering the Clean Area” and “Establishing an Environmental Monitoring Programme and Handling of Failures in Microbiology“
Contamination Control in Aseptic Manufacturing | Validation, Monitoring and Process Control | Quality Oversight and Regulatory Compliance
Zielgruppe
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
Zielsetzung
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.
Programm
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
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
Tue, 17 Nov 2026, 9:00 – 17:30 h
Wed, 18 Nov 2026, 9:00 – 17:30 h
All times mentioned are CET
Wed, 18 Nov 2026, 9:00 – 17:30 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"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
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