Dr Jörg Weyermann
GSK Vaccines
Referierende
Robert G. Schwarz
GXP-TrainCon
Petra Falb
AGES - Austrian Agency for Health and Food Ssafety
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
Faye Litherland
FPC Life Syciences
With case studies on new manufacturing buildings and validation of fogging/gassing systems
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.
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.
Background
“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.
Ensuring the expected level of safety is one of the major challenges for all vaccine Producers.
“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.
Ensuring the expected level of safety is one of the major challenges for all vaccine Producers.
Programm
GMP for Vaccines: What to Consider?
- Differences between vaccines and conventional pharmaceutical products
- Classical vaccines: Inactivated and live vaccines
- Control of vaccine strains and cell lines
- Risk of (Cross-)Contamination
- (Bio)safety basics
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
A Safe Product: Virus Inactivation and Virus Removal Techniques
- Basics of validation of product decontamination procedures
- Virus inactivation: principles and methods
- Virus removal methods
- Potential pitfalls
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: The Formulation and Filling of Live Virus Vaccines – A Containment Conundrum
- Balancing GMP aseptic standards with CL2/CL3 containment
- Equipment selection under dual constraints
- Pressure cascades and airflow management
- Practical lessons from case studies
cGMP Issues for Downstream Processing
- General GMP concerns for downstream processing
- (ultra)filtration techniques
- (ultra)centrifugation techniques
- Sterile filtration and aseptic processing
Weitere Informationen
Venue
NH Collection Heidelberg
Bergheimer Straße 91
69115 Heidelberg, Germany
Phone +49(0)6221 1327-0
nhcollectionheidelberg@nh-hotels.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the conference. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days, and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Social Event
On the evening of the first course day, the participants are cordially invited to a dinner. This event is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Contacts
Questions regarding content:
Mr Clemens Mundo (Operations Director), +49 (0) 6221 84 44 42, mundo@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager), +49 (0) 62 21/84 44 25, bauer@concept-heidelberg.de.
Datum & Uhrzeiten
Tue, 27 October 2026, 8:30 – 17:00 h
(Registration and coffee 8:00 – 8:30 h)
Wed, 28 October 2026, 8:30 – 15:30 h
(Registration and coffee 8:00 – 8:30 h)
Wed, 28 October 2026, 8:30 – 15:30 h
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 Biotech Manager"
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E-Mail: info@concept-heidelberg.de
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