European Microbiology Conference and post-conference workshop Validation of Microbiological Methods

European Microbiology Conference and post-conference workshop Validation of Microbiological Methods

Prague, Czech Republic

Seminar Nr. 15762


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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Walid El Azab, Steris, Belgium

Thomas Brinz, Bosch, Germany

Marja Claasen-Willemse, MSD, The Netherlands

Dr Sven M. Deutschmann, Roche Diagnostics, Germany

Carolin Fromm, Labor L+S AG, Germany

Barbara Gerten, Merck, Germany

Prof. Edwin van den Heuvel, The Netherlands

Pieta IJzerman-Boon, MSD, The Netherlands

Gurpinder Kaur, University Freiburg, Germany

Dr Petra Rösch, University Jena, Germany

Jim Polarine, Steris, USA

Kevin Williams, GE Analytical Instruments, USA


This event offers you a unique possibility to become acquainted with ongoing regulatory requirements, the development of microbiological methods for quality and process control as well as with the recent experiences in microbial contamination control.

Speakers from different scopes of pharmaceutical microbiology will give you the chance to get to know the different views on versatile microbiological topics. Also, as a participant you will have ample opportunity to discuss your specific issues with speakers and other participants.

Interdisciplinary Key Note lectures will give you an additional benefit for understanding the current developments in pharmaceutical QC.


The role of pharmaceutical microbiology is getting more and more important. It is also increasingly in the focus of regulators during product submission and inspections. Current challenges are Low Endotoxin Recovery, implementation of alternative microbiological methods and the ongoing issues with contamination control – there were an increasing number of findings in the authority reports. The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.

Target Group

This conference is of interest to professionals in microbiology from

  • Pharmaceuticals and Biopharmaceutical Companies
  • Academic Research Institutions
  • Government Agencies
  • Contract Service Laboratories
who are involved in
  • Contamination Control
  • Monitoring
  • Validation
  • Quality Affairs
  • Regulatory Affairs
  • Research and Development

IMPORTANT information for the post-conference Workshop!

Please note that a laptop is needed for the practical exercises. Also, the “Minitab” software must be installed on this computer. You can download a 30 days trial version of this sofware here:


Biologics Contamination Control

  • Microbiological control
  • The new science of immunological control
Revised ISO Methods for Validation and Detection of Pathogens
  • Revised ISO 16140: Validation of alternative methods
  • Other revised ISO methods: Enterobacteriaceae, Cronobacter, Salmonellae

Current thinking on Burkholderia Cepacia
  • Last Updates on Burkholderia outbreak and contaminations
  • FDA’s current thinking
  • Regulatory expectations
Industry case study: A microbial investigation of contamination by Burkholderia multivorans
  • The role of microbiological analysis
  • The role of subject matter experts
  • Coordination with FDA
PDA’s Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs
for Aseptic Manufacturing Facilities

  • Key Areas of TR No. 70: definitions and inspections, validation, frequencies and rotations, shut downs
  • How this new technical report compares and relates to Europe, Asia, and Latin America

Validation of a Rapid Sterility Test – Realisation from the Perspective of a Contract Laboratory
  • Implementation and validation of an ATP Bioluminescence method for rapid sterility testing
  • Comparison of the requirements of Ph. Eur. 5.1.6, USP <1223> and PDA TR 33 for the validation of a RMM
  • Results of the method validation and equivalence testing of a selected spectrum of various products
Container Closure Integrity Testing at Frozen Conditions
  • Possible risks at frozen conditions
  • Limitations of CCI testing at room temperature
  • Direct assessment of Container Closure Integrity by a physical method
Paperless Laboratory
  • System architecture
  • Paperless laboratory
  • LIMS modules
Automated Quality Control of highly purified Water to Water for Injection
  • Modular approach of lab automation solutions
  • Development of new modules for water analysis
  • System performance
  • Data handling of results
Microbial Contamination Control and Implications on non-sterile Batch/Equipment Release
  • Objectionable microorganism’s definition
  • Design-effective cleaning and sanitization procedures (process equipment,
  • clean room & water system)
  • Categorize the objectionability and propose a risk-based decision making
  • to assess product quality impact prior to product release
  • Case studies of common cause for microbial contamination
How to reduce the Spreading Effect of Bacteria from the Environmental Monitoring
  • Does 1 cfu really spread?
  • Test of different growth media and inactivators
  • Test of different incubations conditions on spreading
The optimal experiment for validation of qualitative RMMs
  • How to create samples: independent or from one stock? How to quantify the performance of the method?
  • How many test samples needed, with which spike level?
Cultivation-free Raman spectroscopic Identification of Bacteria
  • Technical background
  • Pros and Cons
  • Possibilities, pitfalls and limitations

Post-conference Workshop "Validation of Microbiological Methods"

For the validation of microbiological test methods, several experiments must be performed to demonstrate that the new method is capable of detecting and counting organisms in test samples and at least as good as the compendial method. To quantify the performance, statistical methods form an indispensable tool. This workshop will provide information on the types of experiments and the statistical analyses that may be performed to estimate the validation parameters of the new rapid methods. The methods will be illustrated with real cases on the validation of rapid microbiological test methods.

General Part
  • Guidelines
  • Equivalence
  • Statistical detection
  • Proposed Strategies
Quantitative Methods
  • Statistical detection
  • Accuracy
  • LOD & LOQ
  • Linearity
  • Precision
Qualitative Methods
  • Most Probable Number
  • Specificity
  • Accuracy
  • LOD
  • Two-factor experiment
  • Multi-factor experiments
  • Approaches qualitative & quantitative methods
Closing remarks


GMP Seminare nach Thema

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