 Rapid Microbiological Methods Conference 2010
8th and 9th December 2010, Budapest, Hungary
With Representatives of European and US Authorities
Dear Colleagues,
Until today, traditional
microbiological methods are used in most pharmaceutical QC laboratories.
Rapid Microbiology Methods (RMMs) provide significant advantages for
pharmaceutical companies to obtain data with higher accuracy and
precision compared to traditional methods, testing may be more cost
effective, and the use of RMM allow for coordinated process analytical
technologies to be fully integrated within the manufacturing processes.
In the past decade, many research and development activities focused on
the study and implementation of improved methods for isolation, early
detection, characterization, and enumeration of microorganisms.
With the programme at hand I would like to invite you to the „Rapid
Microbiological Methods Conference“, organised by the European
Compliance Academy (ECA). This conference intends to provide a
microbiological update in RMM and to share experiences from
pharmaceutical companies implementing such new technologies and getting
them approved.
The focus of this conference will be on the different aspects of RMM in:
It is also the aim of this conference to support you with information
about Mycoplasma testing, experiences in fields near to pharmaceutical
microbiology as well as future expectations relative to RMM.
In addition you will get the possibility to discuss the state-of-the-art
and current experiences with RMM with speakers, suppliers and your
colleagues from regulatory authorities and industry.
It would be a great pleasure for me to welcome you in Budapest. It
promises to be an outstanding experience.
Dr Sven M. Deutschmann
Chairman of the ECA RMM Working Group
Highlights
-
US Regulatory View
-
European Regulatory
View
-
Case by Case Risk
Assessment
-
MALDI TOF
Implementation
-
Case Studies:
Industrial Experiences with RMM Implementation
-
Mycoplasma Testing
-
Bacterial Endotoxin
Testing
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