Course No 15961
|Non-ECA Members:||EUR 1790,--|
|ECA Members:||EUR 1590,--|
|EU GMP Inspectorates:||EUR 895,--|
|APIC Members (does not include ECA membership):||EUR 1690,--|
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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.
“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.
The course is designed for personnel of pharmaceutical industries, their suppliers and regulatory bodies who
GMP for vaccines: What are the issues?