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
This course is part of the GMP Certification Programme "ECA Certified Biotech Manager" Learn more
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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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