GMP for Vaccine Manufacturers - Current regulatory requirements and practical implementation
Barcelona, Spain
Course No 16430
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
Speakers
Dr Robert Eskes, Novartis Technical Operations, Austria
Mag. Petra Falb, AGES - Austrian Agency for Health and Food Safety
Dr Andreas Neubert, IDT Biologika
Dr Volker Öppling, PEI, German Federal Institut for Vaccines and Biomedicines
Robert Schwarz, FH Campus Vienna, Austria
Dr Jörg Weyermann, GlaxoSmithKline
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 Course 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 with speakers and other participants about specific issues.
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”. The FDA has issued a draft guideline on new cell substrates for vaccine manufacturing to detail requirements in this area.
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 the 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 safety is one of the greatest challenges of all vaccine producers.
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
Programme
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
- Types of vaccines available
- Manufacturing of classical/modern bacterial vaccines
- Challenges in manufacturing (quality/regulatory issues)
- New technologies and products
- Requirements for raw and starting materials
- Efficient process and product control
- Setting specifications adequately
- Appropriate tests and assays for product release
- Stability testing
- Viral safety aspects
- TSE compliance
- How to deal with OOS results?
- Requirements for early and late clinical trial phases
- 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
- Practical issues with flow of material, personnel and waste material
- Clean room qualification
- Segregation of cell preparation, virus production and downstream processing
- Change over procedures for manufacturing campaigns
- Different gassing systems
- System qualification
- Requirements and Guidelines
- Differences Vaccines Products and Plasma Products
- Use of S3 Coveralls
- Environmental Health and Safety challenges
- Examples from daily business
- Decontamination of surfaces
- Validation of decontamination procedures
- Virus inactivation: principles and methods
- Virus removal methods
- GMP issues on virus inactivation and virus removal techniques
- General GMP concerns for upstream processing
- Raw materials and media preparation
- Cell culture
- Virus culture
- Inactivation of microorganisms
- 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 IMPD´s
- General GMP concerns for downstream processing
- (ultra)filtration techniques
- (ultra)centrifugation techniques
- Sterile filtration and aseptic processing
- Requirements of design
- Issues of construction
- Qualification challenges
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