Dr. Florian Witte
Boehringer Ingelheim
Referent:innen
Wolf-Dieter Wanner
Consultant
Dr. Björn Wiese
Janssen Cilag
Michael Grosser
Lonza Biologics
Zielsetzung
The Online Training is designed for people working in sterile manufacturing to get basic knowledge of GMP.
- You get to know the most important pharmaceutical regulations for sterile manufacturing and their importance,
- You get a basic overview of general GMP requirements and specific requirements in sterile manufacturing and
- You become familiar with the most important basic processes in sterile pharmaceutical production.
Hintergrund
Knowing and applying the GMP regulations is one of the key elements in 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?
The aim of the Online Training is to help answer this question and enable the concrete transfer of regulatory requirements into practice. Where are the main difficulties and how can they be solved pragmatically? The Online Training will present elements and situations which employees are regularly confronted with, like for example:
- Correct cleaning / disinfection
- Behaviour in clean rooms
- Correctly passing into the clean rooms
- Environmental Monitoring
- Performance of Media Fills
Zielgruppe
The Online Training is directed to staff from the healthcare industry having no or little experience with the current GMP requirements for sterile manufacturing. This includes both employees who, after their vocational training, enter the pharmaceutical industry and experienced colleagues who work for the first time in sterile manufacturing areas. Suppliers who have to understand the quality requirements of their customers should also attend this Course.
Date & Technical Requirements
Date of the Live Online Training
Tuesday, 4 November 2025, 09.00 h – 17.30 h CET
Wednesday, 5 November 2025, 09.00 h – 17.30 h CET
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.
Programm
Gesamtes Programm als PDF herunterladen
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
Microbiological Basics
- 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
- Definitions
- Requirements - results – parameters
- Types of detergents and disinfectants
- Microbiological efficacy
- Compatibility of materials
- Types of application
- Surface wetting
Hygiene
- General definitions
- Purpose and function to pharmaceutical manufacturing with reference to personnel, surfaces, equipment
- Diversity of hazard – hazard analysis
- Clean room conception
- Gowning procedures
- Decontamination procedures
Case Study: Entering the Clean Area
- Requirements
- How to meet the criteria - practice
Entering a clean area is a very critical step to fulfil the GMP requirements. Employees must be trained and qualified and the gowning process must be validated. Attendees will learn different procedures and discuss the advantages and disadvantages.
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
Contamination Control Strategy (CCS)
- Something new?
- Requirements from EU GMP Guide Annex 1
- What does CCS include?
Media Fill
- Regulatory requirements
- Microbiological media types
- Process simulation contamination
- Sample incubation
- Laboratory work
- Formal report
Handling failures in Sterile Manufacturing
- Historic 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
| ECA-Member*: | € 1690,- |
| Non ECA Member*: | € 1890,- |
| EU/GMP Inspectorates*: | € 945,- |
| APIC Member Discount*: | € 1790,- |
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
Seminarprogramm als PDF
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