. European Microbiology Conference 2018 .

European Microbiology Conference

on 25 - 26 April 2018

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

Background

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 was 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

Moderator

Dr Marcel Goverde, MGP
Vice Chair of ECAs Pharmaceutical Microbiology Working Group

Programme

	Automation in the QC Microbiology Lab: Implementation of the Charles River Nexus™ testing system Scott Kaszuba Evaluating the Nexus system Validation points to consider Data Integrity related to the Nexus system
	ECA Guidance for Microbiological Environmental Deviations in Non-Sterile Manufacturing Marcel Goverde, MGP \| David Roesti, Novartis Differentiation between critical and non-critical deviations Clear definition of actions to be taken Needs for final approval by QA Propositions for control levels
	Quantitative evaluation of microorganisms recovery from surfaces using contact Jeanne Grosselin, bioMérieux Evaluation of the recovery discrepancies of different microorganisms using contact plates Performance evaluation of the recovery of microorganisms with contact plates application Influence of different types of surfaces and different contact plates suppliers on microorganisms recovery
	Validation of an Alternative Microbial Enumeration Assay Sven Deutschmann, Roche Introduction Requirements Method Validation
	Validation of Microbiological IPC Methods Petra Parizek, Laves IPC of biofermentation samples Practical examples of validation approaches
	Automation in Clinical Microbiology and/or Bacteria Reference Standards Isabelle Bekeredjian-Ding, Paul-Ehrlich Institut Current technical possibilities for automation of microbiological methods Pros and cons of the available techniques How automation contributes to standardization of microbiological QC How these methods can improve microbiological QC of biomedicines
	How to handle Spreader Bacteria Marcel Goverde, MGP What is the spreading phenomenon? How many CFUs are needed to spread? How can spreaders be inhibited?
	Common failure observed during autoclave and sterilization validation and routine monitoring – case studies Walid El Azab, Steris Corporation Discuss the top microbiological considerations when validating, requalifying and routine use of steam sterilization. Impact of the different regulatory updates (EMA and future Annex 1 guidance) from an end-user perspective. Common mistakes and lessons learned regarding steam sterilization autoclaves including Steam in Place (SIP) systems using case studies
	MuScan as a direct detection method of bioburden in column rinse samples Marja Claassen-Willemse, MSD Pieta C. IJzerman-Boon, MSD Comparability of MuScan with compendial method Analysis of non-CFU counts in water matrix
	Next generation sequencing (NGS) and microbiological quality control Elena Bolchakova, Thermo Fisher Scientific Viral detection with massive parallel sequencing of the amplified viral genomic tags Benefits of MPS or NGS Possible Challenges like host cell background Current conclusions
	Rapid Micro Methods Development and Global Deployment approach at Merck Mousumi Paul, MSD Vision and Strategy for Global Deployment of RMMs at Merck Business Case development to facilitate adoption Phases from development of Technology to implementation of RMMs in routine Overcoming challenges associated with the Implementation of Rapid Micro Methods Case studies/examples
	Unique global collaboration through BPOG and Microbial control Vision Mousumi Paul, MSD Mission, Benefits of membership with BPOG 6 Phorums covering all aspects of biopharma operations Microbial control Workstream efforts Vision and Five Year Plan for implementation
	Modern Micro Methods and their LOD Edwin van den Heuvel, University of Eindhoven Probabillity of Detecting Contaminations The USP Approach – Risk Based or not Relationship of LOD and Sampling Plan How to handle it in Practice
	Different matrices require different solutions Carolin Fromm, L+S AG Different Matrices Selection of the best fit rapid method for sterility test Pros and cons