European Microbiology Conference
Im Auftrag der ECA Academy

9-10 May 2017

Prague, Czech Republic

Seminar Nr. 15754

Unser Seminarservice

Kosten

Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Zielsetzung

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.

Hintergrund

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.

Zielgruppe

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

Programm

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

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European Microbiology ConferenceIm Auftrag der ECA Academy