8th European Microbiology Conference with pre-conference workshop "Microbiological Deviations (OOS/OOL)"

8th European Microbiology Conference with pre-conference workshop

Prague, Czech Republic

Course No 9284


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Dr Jessica Cole, FDA/CDER Office of Pharmaceutical Quality’s Division of Microbiology
Dr Stefanie Bayer, Labor L+S AG
Dr Jörg Degen, Bioservice Laboratories
Dr Sven M. Deutschmann, Roche Diagnostics
Dr Wolfgang Eder, Roche Diagnostics
Dr Anja Friedrich, BSL
Barbara Gerten, Merck Millipore
Laura Guardi, Ecolab
Dr Annett Kilic, Greiner Bio-One
Neil Lewis, Procter & Gamble
Dr Paul Lukes, GlaxoSmithKline
Esther Marty, Novartis
Carsten Moschner, Dastex
Dr Rocco Petrizzo, TSI
Jim Polarine, Steris
Dr Guy Roehrig, Lilly
Dr David Roesti, Novartis
Dr Anna Scherzinger, Hyglos
Dr Freimut Wilborn, Berlin Chemie


Pre-Conference Workshop “Microbiological Deviations”
5 May 2015, Prague, Czech Republic

Handling of OOL/OOS Results in Biopharmaceutical Manufacturing
Limit Definitions
Deviation Management
Case-by-Case Assessment of Bioburden Excursions
Dr Sven M. Deutschmann, Roche

EM Deviation Strategy - Non Sterile Drug Product Manufacturing
Clear differentiation between initial non-critical and critical deviations
Established standard procedure
Clear criteria for evaluation
Dr Esther Marty, Novartis

OOS in Sterility Testing
Regulatory Requirements
Immediate Measures and Root Cause Analysis
Deviation Report
speaker to be named

Pharmaceutical Water Qualities – Handling of OOS/OOL Results
Definition of OOS and OOL
Regulatory requirements
Assessment and root cause analysis
Alert levels and trending
Dr Wolfgang Eder, Roche Diagnostics

Dealing with OOS results in endotoxin testing
Definition of OOS and OOL
What is an OOS result
The previous “FDA Guideline” approach
Our current approach
Roles and responsibilities
Analytical and technical investigations
Decision making process
Conclusions and remarks
Dr Guy Roehrig, Lilly

OOS and objectionable microorganisms in non-sterile drug products
Important points to consider when performing root cause investigations
Objectionable microorganisms: risk assessment and origins of contamination
Examples of real cases
Dr David Roesti, Novartis

European Microbiology Conference
6-7 May 2015, Prague, Czech Republic

Agency’s current thinking on microbiology related topics
Regulatory Developments/Microbiological Inspection Experiences/
Control Sterile Products
Dr Jessica Cole, FDA/CDER Office of Pharmaceutical Quality, Division
of Microbiology Assessment
Module 1: Methods and Method Validation

BioTrak - Three Portable Instruments in One
BioTrak Real-Time Data – Benefits
RMM Challenges
Real Case Studies: BioTrak Applications
Rocco Petrizzo, TSI

Validation of an Automated Rapid Bioburden Enumeration System for
Pharmaceutical Water Testing
Validating the Growth Direct System against common microorganism isolates found in pharmaceutical water systems
Stressed organism validation method and results
Time-to-Result determination
LIMS integration with Growth Direct system for direct data entry
Paul Lukes, GlaxoSmithKline

A newly developed approach for the rapid detection and identification of
adventitious viruses in biopharmaceuticals
The background
The idea/principle
The assay performance
Dr Annett Kilic, GBO

Evaluation of classical and modern methods for bacterial identification: Comparison of VITEK®-2 compact (biochemical analysis ) to VITEK®-MS (MALDI-TOF mass spectrometry) and MicroSeq® Microbial Identification System (16S-rDNA sequencing)
Brief introduction of the various identification methods and their pros and cons
Comparative identification of microorganisms from hygiene monitoring using biochemical as well as molecular methods
Which method is most suitable for which purpose?
Dr Stefanie Bayer, L+S AG

New Bioindicators for H2O2 Sterilisation
Highest quality indicators
Homogenous spore layer
Lot size (up to 50000 indicators)
Dr Anna Scherzinger, Hyglos GmbH

Qualification/Validation of moist heat and dry heat sterilization processes:
Microbiological Studies
Design of microbiological studies within the Qualification/Validation of moist heat and dry heat sterilization processes
Usage of bioindicators and endotoxin indicators
Case-studies and problems
Anja Friedrich, BSL

Module 2: Contamination Control and Disinfection

Validation of Disinfectants for use in Cleanrooms
The process for evaluation of disinfectants to be used in cleanrooms
Review of disinfectant testing methods and their suitability for evaluation of cleanroom disinfectants
Points for consideration when defining the validation protocol
Laura Guardi, Ecolab

New Studies – Light induced disinfection of garment and surfaces
New innovative cleanroom textile with a light induced self-disinfection
Mechanism and efficacy
Conception of gowning areas for such new garment system
Carsten Moschner, Dastex

Solutions for overcoming testing challenges with disinfectant coupon studies
Fungal and Bacterial spore case studies in cleanrooms will be covered.
Advances in cleaning and disinfection methods will be covered.
Industry regulations and warning letters will be covered related to disinfectant qualification and spore outbreaks.
Common causes for coupon testing failures will be covered and solutions will be covered to overcome obstacles.
Jim Polarine, Steris

Holding Studies and Microbial Challenge Tests
Review of some challenges in Antimicrobial Effectiveness Testing of preserved and
non-preserved products
Microbial growth promotion test and determination of growth rates for different test strains
Microbial Challenge Test and Bioburden simulation
Case studies and failure investigations
Jörg Degen, BSL
Module 3: Learning from cognate industries

Implementation Modern Microbiological Methods at Cosmetic Manufacturing
The thought processes and criteria for the selection of rapid methods
Difficulties and issues during implementation
Combination of rapid and traditional methods
Need for an industry wide approach
Speaker to be named

Further Developments of ISO Methods Revision
Validation of alternative methods in food and drinking water testing
New and revised ISO methods in food and water testing
Barbara Gerten, Merck

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