European Microbiology Conference
Im Auftrag der ECA Academy

European Microbiology Conference  Im Auftrag der ECA Academy

Barcelona, Spain

Seminar Nr. 17841


Kosten

HABEN SIE INTERESSE AN DEM SEMINAR?

Bitte kontaktieren Sie uns und wir informieren Sie:

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

Sprecher

Dr Emmanuell Charton, EDQM
Dr Marja Claassen, MSD
Jordi Iglesias Cullell, CRL
Dr Sven M. Deutschmann, Roche
Dr Elena Ferber, Labor LS
Stefan Gärtner, Labor LS
Mike Gajdiss, Lonza
Dr Viviane Grunert da Fonseca, Roche
Peter Huonker, Früh Verpackungstechnik
Dr Pieta IJzerman-Boon, MSD
Dr Michael Miller, Microbiology Consultants LLC
Dr Kai Nesemann, Sartorius
Maria Eugenia Giribets Parra, Boehringer Ingelheim
Dr Wolfgang Rudy, TentaMedix
Dr Michael Ruffing, Boehringer Ingelheim
Alexandra Stärk, Novartis Pharma Stein
Dr Steffanie Strathdee, UCSD Department of Medicine
Dr Ulrich Zuber, Hoffmann-La Roche

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.

Hintergrund

The role of pharmaceutical microbiology is getting more and more important. The microbial control concept also increasingly in the focus of regulators during product submission and inspections. Current challenges are Endotoxin-masking effects (“Low Endotoxin Recovery”), implementation of alternative microbiological methods, control of cell based products 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
  • Pharmaceutical and Biopharmaceutical Companies
  • Academic Research Institutions
  • Government Agencies
  • Contract Laboratories
 
who are involved in
  • Contamination Control
  • Monitoring
  • Validation
  • Quality Affairs
  • Regulatory Affairs
  • Research and Development

Programm

Keynote: Necessity is the Mother of Invention:  Why Phage Therapy is Making a Comeback in the West
Steffanie Strathdee, PhD, UCSD Department of Medicine
  • The presenter will describe her family’s personal story as it relates to the current revitalization of phage therapy
  • The presenter will briefly describe the strange history of phage therapy and why it was ‘forgotten’ in the West
  • The presenter will discuss current and future prospects for phage therapy using natural, genetically engineered and synthetic phage
Current activities with relevance to microbiology
Dr Emmanuelle Charton, EDQM
  • Rapid methods
  • BET/rFc/MAT
  • Extraneous agents
  • others
Evaluation of Next Generation Sequencing (NGS) for Adventitious Virus Testing
Dr Michael Ruffing, Boehringer Ingelheim
  • Current Regulatory Background and Activities
  • Replacing compendial Methods – Case Studies
Definition of a microbiological contamination control strategy for a new launch product
Alexandra Stärk, Novartis
  • Relevant parameters of a microbiological contamination control strategy
  • Critical and non-critical process parameters
  • Required validation studies
Development and validation of a rapid sterility test using BacT/ALERT Dual T
Dr Marja Claassen & Dr Pieta IJzerman-Boon, MSD
  • Development of method to enable detection of Cutibacterium acnes
  • Design of experiments for solving diminished mold detection
  • Validation of improved method according to Ph.Eur. 5.1.6 and USP<1223>
  • Innovative statistical validation approach to demonstrate non-
  • inferiority with compendial method
Rapid Microbiological Methods for Bioburden testing of air and water and the long way towards implementation
Dr Ulrich Zuber, Roche
  • Devices for online monitoring of water and air
  • Feasibility studies
  • Steps to implementation
  • Oppportunities for RMM due to the new version of Annex 1
Growth Direct System Experiences
Mike Gajdiss, Lonza
 
Continuous microbiological air monitoring  
Dr Kai Nesemann, Sartorius
 
Case Study - Comparison of Monitoring Systems
Peter Huonker, Early Packaging Technology
  • Application area and function
  • Comparison of two monitoring systems – Valimon from ValiSys and Labwatch Monitoring from GE (Amphenol)
  • Pros/Cons
Rapid microbial test for short shelf life pharmaceuticals
Dr Kai Nesemann, Sartorius
 
Determination of Pyrogens from Medical Devices/MAT Multiplexing
Dr Wolfgang Rudy, TentaMedix
 
  • Endotoxin vs. Non Endotoxin Pyrogen detection in vitro
  • Monocyte Activation Test as in vitro replacement of the Rabbit
  • Pyrogen Test
  • Pyrogens and Medical Devices
  • Cytokine multiplexing
Pyrogen Detection on cellular prepartions and other short shelf life pharmaceuticals
Stefan Gärtner, Labor LS
  • Regulatory requirements
  • Test Methods and Strategies
  • Test Interferences
  • Low Endotoxin Recovery
Strategies for validating nucleic acid-based techniques for testing for the absence of Mycoplasma
Dr Elena Ferber, Labor LS
  • Characteristics of mycoplasmas
  • NAT-Techniques
  • Strategies for validation/suitability tests
  • Pitfalls and practical examples
The new ECA OOS/OOT Guide on Endotoxin Testing
Jordi Iglesias Cullell, CRL
  • OOS/OOT/Atypic versus Invalid
  • Define a OOS flowchart
  • Organizational tools for conducting Investigations
  • OOS investigation Check-List

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