Other Events of Interest

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

Microbiology for Non-Microbiologists, 2-3 February 2010 Prague, Czech Republic
It is the aim of this course to familiarise responsible personnel from production, quality assurance and engineering with microbiological questions. The participants learn how to interpret microbiological data and which consequences these have for the production.

http://www.gmp-compliance.org/eca_seminar_6360.html

Microbiological Best Laboratory Practices, 22-24 February 2010 Vienna, Austria
Most tests applied in microbiological QC are described in detail in the different Pharmacopoeias (e.g. EP, USP, JP). These methods are regarded as being validated – but not for your products!

In the end, it is up to you to prove that the official methods function in your environment. The validation of microbiological test methods for your needs consumes a lot of time, money and manpower. Things can get more complicated if your products interfere with the execution of the test.

The real challenge is to fulfil both, regulatory requirements and at the same time financial targets set by your management.

During this 3-day workshop you develop strategies for a sustainable approach to the validation of microbiological test procedures. This course will give you clear guidance on how to cope with these tasks besides your routine laboratory work.

The key tool of this seminar will be team work. During interactive sessions you will create procedures for the most common microbial test methods. Our experienced ECA course leaders will moderate the discussions to lead you to practice-oriented solutions.

After completion of the course you will be able to cope with the validation of microbiological test procedures in a compliant and at the same time efficient manner.

To guarantee optimal conditions for the exchange of opinions and experiences, the number of participants is limited!

http://www.gmp-compliance.org/eca_seminar_6290.html

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, 18-19 May 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