. 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

	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
	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
	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
	Development of a highly sensitive PCR/DNA chip method to detect mycoplasmas in a modified live vaccine Blandine de Saint-Vis, Boehringer Animal Health Kathrin Koeck,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
	Validation of Hold Times for aseptic processing Sebastian Thölken, Novartis Overview of relevant hold times: product hold times & equipment hold times Validation approaches Experiences from Inspections and Product-Submissions
	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
	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
	Qualification of Laboratory Heaters and Refrigerators Patrick Koch, CSL Behring Differences of Temperature Mapping - the Past and Today Implemention of : DQ/IQ/OQ/PQ
	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
	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
	Microbiological Aspects of Filter Validation Matthias Schaar, Novartis Requirements How to set up a microbiological filter validation How does the Integrity test correlates to bacterial retention
	Contamination control and company culture – A Case Study of a Microbiological Contamination Dr. Ulrich Herber, CRL What happened? What should have happened? Company culture Putting in into perspective
	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
	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

European Microbiology Conference

on 08 - 09 May 2019

Background

Target Audience

Moderator

Programme

Current and recent activities of the USP Microbiology Expert Committee

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

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

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

Validation of Hold Times for aseptic processing

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

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

Qualification of Laboratory Heaters and Refrigerators

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

Microbiological Control of Primary Packaging

Microbiological Aspects of Filter Validation

Contamination control and company culture – A Case Study of a Microbiological Contamination

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

Risk-based aseptic process step simulation for automated cell processing