Classic and Modern Technologies - Regulatory Requirements and Practical Implementation
27/28 October 2026, Heidelberg, Germany
Course No. 22590
Speakers
Robert G. Schwarz
GXP-TrainCon
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
With case studies on new manufacturing buildings and validation of fogging/gassing systems
Target Group
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.
Objectives
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.
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.
Programme
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
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.
Testimonials
