Other Events of Interest

The European Compliance Academy has developed additional conferences and courses to address important aspects of microbiology:

Virus and TSE Safety made simple, 22-23 September 2010, Munich, Germany

Viral safety is one of the major concerns in the development and production of biopharmaceuticals and biologics. Huge efforts are undertaken to prevent viral contamination. A series of guidelines was dedicated to that topic exclusively.

For many people who are involved in the development and production of biopharmaceuticals and biologics the world of viruses is a "black box".

It is the aim of this course to enlighten this world between "dead and alive".

The nature of viruses postulates significant differences to micro-organisms. This uniqueness poses particular challenges to the detection, inactivation and removal of viruses.

All these specifics will be discussed in detail at this education course – in an understandable manner.

Another threat poses TSE (Transmissible spongiform encephalopathy). Numerous studies have been conducted to understand the route of transmission and the causing agents better. Nevertheless, misunderstandings and rumours circulate and cumulate in the statement: "We need a TSE certificate for our activated charcoal."

This course will give you a scientifically sound introduction into the field of TSE and the impact on the pharmaceutical industry.

http://www.gmp-compliance.org/eca_seminar_6440.html

Microbiological Culture Media, With a visit of bioMérieux’s media manufacturing site in Lyon, 26-27 October 2010, Lyon, France

The formulations of many microbiological media are described in the Pharmacopoeias but with the international harmonisation activities a lot of changes took place.

During this Education Course, you will get familiar with all GMP-relevant aspects of culture media. Experts from pharmaceutical industry and media manufacturing will show you their approach in practise and share their experience from daily business.

http://www.gmp-compliance.org/eca_seminar_6376.html

Contamination Control, 9-11 November 2010, Prague, Czech Republic

In most cases the implementation of appropriate hygiene programmes and measures have been implemented as an essential part for the manufacturing of pharmaceutical products. A series of regulations address the subject of microbiological facility control.

The overall goal of such a system is to prevent microbiological contamination of the pharmaceutical product. But even if such a system has been established, it is of utmost importance that these programmes and measures are understood and followed by all operators who carry out quality-relevant work. Therefore, regulations demand intensive training in hygiene issues.

Against the background of these requirements, this ECA education course is designed to cover all important aspects of controlling microbiological contamination. It ranges from sources of contamination to microbiological validation of processes and training of operators. A focus will be on those problems that occur frequently in pharmaceutical production; possible solutions to these challenges will be discussed.

Furthermore, this education course clarifies uncertainties concerning microbiological facility control and provides helpful suggestions for compliance with regulatory demands. Experienced specialists share their expert knowledge with the participants.

http://www.gmp-compliance.org/eca_seminar_6485.html