. European Microbiology Conference 2019 .

European Microbiology Conference

on 08 - 09 May 2019

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 lectures will give you an additional benefit for understanding the current developments in pharmaceutical QC.

Background

The role of pharmaceutical microbiology is getting more and more important. The microbial control concept is also increasingly in the focus of regulators during pro-duct submission and inspections. Current challenges are Low Endotoxin Recovery or other Endotoxin-masking effects, implementation of alternative microbiological methods, control of cell-based products and the ongoing issues with contamination control – there was an increasing number of findings in the authority reports.

The challenge is therefore to satisfy regulatory requirements alongside management’s financial expectations.

Target Audience

This conference is of interest to professionals in microbiology from:

  • Pharmaceutical and biopharmaceutical companies
  • Academic Research Institutions
  • Government agencies
  • Contract service laboratories

who are involved in

  • Contamination control
  • Monitoring
  • Product Testing
  • Validation
  • Quality affairs
  • Regulatory affairs
  • Research and development

Moderator

Dr Marcel Goverde, MGP
Vice Chair of  ECAs Pharmaceutical Microbiology Working Group

Programme

 Radhakrishna Tirumalai

Current and recent activities of the USP Microbiology Expert Committee

Radhakrishna Tirumalai, USP

  • Recent approvals of new chapters and revisions (<1211>, <1222>)
  • Recent major proposals in PF ( <1085, <1071>, <60>)
  • Future plans 

 

 Barbara Gerten

What the Neighbours have learned – Validation of Methods – The Guidance for Food Microbiology

Barbara Gerten, Merck
  • Introduction to ISO 16140 Method Validation
  • Validation of reference and alternative methods
  • Verification during implementation in the laboratory

 

 Peter Huonker

Monitoring Sytems – Requirements and Experiences Monitoring Sytems – Experiences with Valimon and Labwatch

Peter Huonker, Früh Verpackungstechnik

  • Why and when do you need a monitoring system?
  • Experiences with two different systems
  • Pro’s and Con’s

 

 Blandine de Saint-VisAnnett Kilic

Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a modified live vaccine

Blandine de Saint-Vis, Boehringer Animal Health
Annett Kilic,Greiner Bio-One

  • CytoInspect as a test sytem for the rapid detection and identification of mycoplasmas
  • Methodology and preparation of spiked samples
  • Use of 5 Eur. pharmacopoeial reference strains of mycoplasmas
  • Validation criteria of limit of detection
  • Sensitivity and specificity of the method in a modified live vaccine

 

 Alexandra Stärk

Validation of Hold Times for aseptic processing

Alexandra Stärk, Novartis

  • Overview of relevant hold times: product hold times & equipment hold times
  • Validation approaches
  • Experiences from Inspections and Product-Submissions

 

 Erika Pfeiler

Status Updates:  Current Topics in Quality Microbiology at the FDAAn overview of the quality microbiology review process

Erika Pfeiler, FDA

  • A description of quality microbiology related policy initiatives
  • A discussion of current information requests frequently sent to applicants

 

 Ulrich Zuber

IMD-W “In-line system for purified water systems” and other decvices for rapid water bioburden analyses

Ulrich Zuber, Roche

  • Feasibility studies as offline device in the lab
  • Feasibility study as online device at a purified water loop
  • Challenges and possiible solutions for online WFI bioburden analysis

 

 Patrick Koch

Qualification of Laboratory Heaters and Refrigerators

Patrick Koch, CSL Behring

  • Differences of Temperature Mapping  - the Past and Today
  • Implemention of : DQ/IQ/OQ/PQ

 

 Robert Schwarz

Microbiology, Personnel and Qualification - who’s affected and what’s included

Robert Schwarz, FH Campus Vienna

  • QC Lab Microbiology - the equipment, the method and the operator and how qualification and validation is handled
  • Aseptic processing - qualification of operators and validation of processes from a microbiological perspective
  • From Guidelines to daily business - examples from the industry

 

 Marcel Goverde

Microbiological Control of Primary Packaging

Marcel Goverde, MGP

  • Guiding documents for the microbiological testing of primary packaging
  • Potential methods and suitability test approaches
  • Acceptance criteria

 

 Matthias Schaar

Rapid Micro Methods Development and Global Deployment approach at Merck

Matthias Schaar, Novartis

  • Requirements
  • How to set up a microbiological filter validation
  • How does the Integrity test correlates to bacterial retention

 

 Speaker Labor LS

Individualized Strategies for the Test of Sterility based on Hygenie Monitoring Evaluation

Speaker Labor LS

 

 Walid El Azab

Recurring Microbial Contamination in grade A (ISO 5) filling Restricted Access Barrier System (RABS)

Walid El Azab, Steris

  • Initial Investigation and Root Cause Analysis
  • Corrective and Preventive Actions
  • Ongoing Deviation
  • Cross Functional Investigation
  • Short- and Long Term CAPA’s

 

 Nadja Gilles

Risk-based aseptic process step simulation for automated cell processing

Nadja Gilles, Miltenyi Biotec

  • Automated processing of human cells with regulatory requirement for media fill
  • Risk analysis based on clustered process steps
  • Aseptic process step simulation shortened by bracketing