European Microbiology Conference 2021
European Microbiology Conference
on 5 - 6 May 2021
Highlights
- Pharmacopoeial Developments and GMP Expectations
- Burkolderia cepacia Complex – Regulatory Requirements and Methodology
- Monitoring and New Methods – from Comparison up to Validation
- Water Activity – USP and Laboratory Experiences
- Endotoxin- and Pyrogen Testing
- ECA - OOS/OOL Guide: New Chapter for Sterility Test Failures
Objectives
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 ask questions in several Q & A Sessions throughout the conference.
Background
The role of pharmaceutical microbiology is getting more and more important. The microbial control concept also increasingly in the focus of regulators during product submission and inspections. Current challenges are Endotoxin-masking effects (“Low Endotoxin Recovery”,, implementation of alternative microbiological methods, control of cell based products 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 Audience
This conference is of interest to professionals in microbiology from:
- Pharmaceutical and biopharmaceutical companies
- Academic Research Institutions
- Government agencies
- Contract service laboratories
who are involved in
- Contamination control
- Monitoring
- Product Testing
- Validation
- Quality affairs
- Regulatory affairs
- Research and development
Moderators
Dr Sven M. Deutschmann,
Roche, Chairman ECA Pharmaceutical Microbiology Working Group
Axel H. Schroeder,
Administration Manager, Pharmaceutical Microbiology Working Group
Programme
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Implementation of European Pharmacopoeia methods: conventional methods versus alternative methodsEmmanuelle Charton, EDQM
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Experiences with Burkolderia cepacia Complex
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Case Study - Comparison of Monitoring SystemsPeter Huonker, Früh Packaging Technology
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Continuous microbial air monitoring for aseptic filling linesDr Kai Nesemann, Sartorius
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Water Activity Part 1 – USP <992>Martin Coffey, USP Expert Volunteer
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Water Activity Part 2 - An important factor forrisk assessmentChristine Weß, Labor LS
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Experiences and Data from OWBA – Online Water Bioburden AnalyserJesper Hjorth, Novo Nordisk
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VBmicro: a suitable lab device for bioburden determination of water and buffers in less than 1 hourDr Ulrich Zuber & Michaela Ann Kinney, Roche
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Inspection of Micro Labs /Expectations of an Inspector on microbiological QCDr Rainer Gallitzendörfer, Local Government of Upper Bavaria
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Performance Testing of Membrane FiltersBarbara Gerten, Merck
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Microbial control in Downstream of biopharmaceutical manufacturingDr Jan Feuser, Boehringer Ingelheim
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Endotoxins versus pyrogen testing: how the European Pharmacopoeia texts can helpIoana Venet, EDQM
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Determination of Pyrogens: optimization of the MAT for Medical Device testingWolfgang Rudy & Larissa Nkenmei-Pietsch, TentaMedix GmbH
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New Chapter of ECAs OOS/OOL Guide: Guidance for sterility test failuresDr David Roesti, Novartis
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