. 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

 Audrey Meade

QA Oversight -  environmental improvement program including aspects of the aseptic observer initiative

Audrey Meade, US – Merck/MSD

 

 Marcel Goverde
David Roesti

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

 

 Björn Breth

Q&A on Microbiological Media Challenges

Björn Breth, bioMérieux

 

 Sven Deutschmann

Validation of an Alternative Microbial Enumeration Assay

Sven Deutschmann, Roche

  • Introduction
  • Requirements
  • Method Validation

 

 Petra Parizek

Validation of Microbiological IPC Methods

Petra Parizek, Laves

  • IPC of biofermentation samples
  • Practical examples of validation approaches

 

 Isabelle Bekeredjian-Ding

Automation in Clinical Microbiology and/or Bacteria Reference Standards

Isabelle Bekeredjian-Ding, Paul-Ehrlich Institut

 

 Marcel Goverde

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?

 

 Walid El Azab

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

 

 

New Data for MuScan Validation

Speaker, MSD

 

 Elena Bolchakova

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

 

 Mousumi Paul

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

 

 Mousumi Paul

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

 

 Edwin van den Heuvel

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

 

 Carolin Fromm

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