Rapid Microbiological Methods - Part of PharmaLab 2015

10 November 2015

Düsseldorf/Neuss, Germany

Course No 200026

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Objectives

This conference offers you a unique possibility to evaluate the new developments in RMM systems to extend the experiences in validation as well as implementation of these systems in pharmaceutical industry. Furthermore you will learn more about the expectations of authorities and developments in regulatory requirements. Amongst this, experts from laboratory and industry will give an insight view in the routine use of RMM.

Background

Microbial contamination poses enormous risks to pharmaceuticals and their consumers. To
minimize the quality and financial risk, pharmaceutical and biopharmaceutical manufacturers
collect thousands of samples for bioburden or sterility testing a year. The classic culture
methods are often laborious and require long incubation times. In the field of some biopharmaceuticals,
Advanced Therapy Medicinal Products and other modern products, it is often
not possible to wait 7 or more days for a result. RMMs provide the ability to reduce time
and costs for microbial detection and increase the safety level of the products.
In the meantime several new systems for the detection of microbial contaminants and new identification systems are available at the market or in validation. The regulatory authorities like FDA, EDQM or MHRA assist the implementation of RMMs e.g. with the revision of the related guidelines or pharmacopoeias.

Target Group

This conference is of interest to professionals in Quality, Microbiology and Validation from
..Pharmaceuticals and Biopharmaceutical Companies
..Contract Service and Research Laboratories
..Government Agencies
..Cell Culture Collections

Programme

SILVA & ARB: high quality ribosomal RNA gene databases and services
Prof. Frank Oliver Glöckner, Max Planck Institut & Jacobs University Bremen

Revision of European Pharmacopoeia Chapter 5.1.6
Speaker, EDQM

MICROPRINT BIOCARD: Imprinted Polymer Technology for the Rapid Detection of Microorganisms
Dr. Santosh Padmanabhan, MiCRA-Biodiagnostics, Institute of Technology Tallaght

Validation of a Sterility Test
Anna Mills, Rapid Micro Biosystems

Rapid Enumeration with MU-scan: Risk or Improvement
Jaap Schot/Dr. Pieta Ijzerman-Boon, MSD

Modern Microbiological Safety Concepts – A Regulator´s View on Cell-based Products
Jan-Oliver Karo, Paul-Ehrlich-Institut, German Agency for Vaccines and Biomedicines

Approaches for Validation of Rapid Sterility Testing Methods
Dr. Rajesh Gupta, Biologics Quality & Regulatory Consultants

Identification with MALDI-TOF
Peter Huonker, Zimmer

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