. European Microbiology Conference 2017 .

European Microbiology Conference

on 9 - 10 May 2017

 
 

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 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.


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 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
  • Validation
  • Quality affairs
  • Regulatory affairs
  • Research and development


Moderators

Dr Sven M. Deutschmann, Chairman, ECA Pharmaceutical Microbiology Working Group


Programme

Biologics Are Different - A New Paradigm for Microbiological Contamination Control

  • Microbiological control
  • The new science of immunological control

Kevin Williams, BioMerieux, USA

 

Revised ISO Methods for Validation and Detection of Pathogens

  • Revised ISO 16140: Validation of alternative methods
  • Other revised ISO methods: Enterobacteriaceae, Cronobacter, Salmonellae

Barbara Gerten, Merck

 

FDA perspectives on Burkholderia cepacia and risk-based microbiology review

  • CDER perspective on Burkholderia multivorans contamination case study
  • Regulatory expectations for Burkholderia control
  • Risk-based microbiology quality assessment by CDER 

Bryan Riley, FDA

 

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

Dr Marja Claassen-Willemse, MSD

 

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

Jim Polarine, Steris

 

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

Carolin Fromm, Labor L+S AG

 

Container Closure Integrity Testing for Frozen Drug Products

  • Container Closure Integrity Introduction
  • Latest Regulatory Changes – USP <1207> Revision
  • Container Closure Integrity for Frozen Drug Products
  • Container Closure Integrity Strategy: Holistic Approach

Dr. Roman Mathaes, Lonza

 

Paperless Laboratory

  • System architecture
  • Paperless laboratory
  • LIMS modules

Sven Deutschmann, Roche

 

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

Thomas Brinz, Bosch and Jens Jesse, Biotest

 

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

Walid El Azab, Steris

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Rapid detection of pathogens by IMS and flow cytometry

  • The Cellstream and IMS technology for Legionella
  • Benefits of IMS for plating
  • Viability as a marker for detection

Dr. Claudio Aguilar, rqmicro AG, Switzerland

 

 

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?

Pieta IJzerman-Boon, MSD and Edwin van den Heuvel, Univ. Eindhoven

 

Cultivation-free Raman spectroscopic Identification of Bacteria

  • Technical Background
  • Pros and Cons
  • Possibilities, pitfalls and limitations

Petra Rosch, University Jena