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 the environment and the waste disposal should be receiving proper attention already in the design phase. But the dedicated requirements on staff safety are although a challenge in vaccine manufacturing

This Course should 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 participants 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". FDA has issues 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 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.

Target Audience

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
  

Registration

To register for this course please use one of the following Registration Options.