Dr Robert Eskes
FAREVA Unterach
Referent:innen
Robert G. Schwarz
GXP-TrainCon
Dr Andreas Neubert
Klocke Holding
Dr Jörg Weyermann
GSK Vaccines
Petra Falb
AGES - Austrian Agency for Health and Food Ssafety
Faye Litherland
FPC Life Syciences
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
All times mentioned are CET
Zielsetzung
The development and production of vaccines makes high demands on the manufacturing pharmaceutical industry. The special requirements on handling and safety with live organisms necessitate measures which exceed the requirements of classic pharmaceutical manufacturing.
Topics like the enhanced risk of cross contaminations, questions about individual safety of staff and the issues of cleaning and disinfection of rooms and equipment concern a vaccine manufacturer in a considerable scale.
Specifically, the demands of the necessary bio safety classes with negative pressure of rooms versus that of aseptic processing with positive pressure requires a well thought-out design of vaccine facilities.
Also, the safety of environment and waste disposal should receive proper attention already in the design phase. But the dedicated requirements on staff safety are also a challenge in vaccine manufacturing.
This Live Online Training will give you the possibility to see the theoretical background as well as the practical implementation of GMP requirements in the vaccine production. A combination of theoretical requirements and practical case studies is the best way to learn this.
Speakers from regulatory bodies, consulting and practising experts will give you the chance to get to know the different views and you will have ample opportunity to discuss specific issues with speakers and other participants.
Topics like the enhanced risk of cross contaminations, questions about individual safety of staff and the issues of cleaning and disinfection of rooms and equipment concern a vaccine manufacturer in a considerable scale.
Specifically, the demands of the necessary bio safety classes with negative pressure of rooms versus that of aseptic processing with positive pressure requires a well thought-out design of vaccine facilities.
Also, the safety of environment and waste disposal should receive proper attention already in the design phase. But the dedicated requirements on staff safety are also a challenge in vaccine manufacturing.
This Live Online Training will give you the possibility to see the theoretical background as well as the practical implementation of GMP requirements in the vaccine production. A combination of theoretical requirements and practical case studies is the best way to learn this.
Speakers from regulatory bodies, consulting and practising experts will give you the chance to get to know the different views and you will have ample opportunity to discuss specific issues with speakers and other participants.
Hintergrund
“Vaccines are expected to be very safe” is one of the headlines in the presentation of the CBER “Vaccine safety team”. At the same time, new vaccines are needed for diseases for which currently no vaccine is available, and production technologies need improvement to deal with the shortage of certain types of vaccines. This has led to the emergence of new technologies. One of the important questions from the authorities however is “How safe are the new technologies”. There are several guidelines from the FDA and other authorities that deal with the safety of the different types of vaccines.
In the development of new technologies for the pharmaceutical and biopharmaceutical production of vaccines again the question of GMP compliance and safety is emphasised.
Furthermore, with the Quality Initiative for the 21st Century from the FDA new guidelines have been issued, which have an impact not just on conventional pharmaceutical industry, but also on vaccine manufacturers. Risk management and quality in design are essential in the implementation of new technologies and the introduction of new vaccines.
To assure the expected safety is one of the great challenges of all vaccine producers.
In the development of new technologies for the pharmaceutical and biopharmaceutical production of vaccines again the question of GMP compliance and safety is emphasised.
Furthermore, with the Quality Initiative for the 21st Century from the FDA new guidelines have been issued, which have an impact not just on conventional pharmaceutical industry, but also on vaccine manufacturers. Risk management and quality in design are essential in the implementation of new technologies and the introduction of new vaccines.
To assure the expected safety is one of the great challenges of all vaccine producers.
Zielgruppe
The course is designed for personnel of pharmaceutical industries, their suppliers and regulatory bodies who
- are responsible for quality control and/or quality assurance in vaccine/biopharmaceutical production,
- manage the vaccine production,
- establish the operator protection,
- audit vaccine manufacturers,
- design or operate vaccine production sites.
Date / Technical Requirements / Presentations / Certificate
Date of the Live Online Training
Tuesday, 28 October 2025, 08.30 h – 18.00 h
Wednesday, 29 October 2025, 08.30 h – 16.15 h
All times mentioned are CET.
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 trainings 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.
Tuesday, 28 October 2025, 08.30 h – 18.00 h
Wednesday, 29 October 2025, 08.30 h – 16.15 h
All times mentioned are CET.
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 trainings 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.
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.
Programm
Gesamtes Programm als PDF herunterladen
GMP for Vaccines: What are the Issues?
- Differences between vaccines and conventional products
- Inactivated and live vaccines
- Control of vaccine strains and cell lines
- Risk of (cross-)contamination
- (Bio)safety issues
Regulatory Requirements of Conventional Vaccines
- Critical process steps
- In Process- and final product controls
- Specifications and stability
- Further relevant guidelines
Regulatory Requirements of Modern Vaccines
- Differences to conventional vaccines
- mRNA Vaccines: How to control the process and the final product
- Relevant guidelines and Ph Eur Monographs
- Vaccine platform technology master file
Modern Technology for Vaccine Manufacture
- Clean utilities design and installation - current Trends
- Single use vs reusable technology
- Cell culture methods and equipment
Containment, Biological Safety and Product Protection
- Containment, product safety versus environmental safety
- Primary containment and additional measures
- Negative pressure areas in aseptic manufacturing
- Decontamination of facilities
- Personnel as critical component in containment
Virus Inactivation and Virus Removal Techniques
- Validation of decontamination procedures
- Virus inactivation: principles and methods
- Virus removal Methods
- GMP issues on virus inactivation and virus removal techniques
Validation of a Decontamination System for Production Equipment, Process Devices and Cleanrooms
- Different gassing systems
- System qualification
- Validation of a dry fog detergent
Case Study: Vaccine Facility Design
- Identification of biological risk and management strategy
- Ergonomics for operation, cleaning and maintenance
- Designing for the future (expansion, change of manufacturing method, change of product)
Inspection of Vaccine Manufacturer – Topic of Focus & Common Issues
- Navigating the world of GMP Guidelines
- Topics in GMP inspections
- How to deal with observations?
cGMP Issues for Upstream Processing
- General GMP concerns for upstream processing
- Raw materials and media preparation
- Cell culture
- Virus culture
- Inactivation of microorganisms
Issues of Staff Safety
- Requirements and guidelines
- Differences vaccines products and plasma products
- Use of S3 coveralls
- Environmental health and safety challenges
- Examples from daily business
Case Study: Isolator Filling Line for Vaccines
- Requirements of design
- Issues of construction
- Qualification challenges
cGMP Issues for Downstream Processing
- General GMP concerns for downstream processing
- (ultra)filtration techniques
- (ultra)centrifugation techniques
- Sterile filtration and aseptic processing
Case Study: GMP Development and Manufacturing of Recombinant Viral Vaccines for Clinical Trials
- Regulatory expectations for vaccine batches for phase 1/2/3 clinical Trials
- Development vs. Validation
- Regulatory expectations for implementation of analytical methods – qualification and validation
- Contract manufacturing of IMPDs
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This course is part of the GMP Certification Programme "ECA Certified Biotech Manager"
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