Course No 16328
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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.
The role of pharmaceutical microbiology is getting more and more important. It is also increasingly in the focus of regulators during product submission and inspections. Current challenges are Low Endotoxin Recovery, implementation of alternative microbiological methods 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.
This conference is of interest to professionals in microbiology from
Pharmaceuticals and Biopharmaceutical Companies
Academic Research Institutions
Contract Service Laboratories
who are involved in
.Research and Development
QA Oversight - environmental improvement program including aspects of the aseptic observer initiative
Audrey Meade, US – Merck/MSD
ECA Guidance for Microbiological Environmental Deviations in Non-Sterile Manufacturing
Marcel Goverde, MGP
David Roesti, Novartis
Differentiation between critical and non-critical deviations
Clear definition of actions to be taken
Needs for final approval by QA
Propositions for control levels
Q&A on Microbiological Media Challenges
Björn Breth, bioMérieux
Validation of an Alternative Microbial Enumeration Assay
Sven Deutschmann, Roche
Validation of Microbiological IPC Methods
Petra Parizek, Laves
IPC of biofermentation samples
Practical examples of validation approaches
Automation in Clinical Microbiology and/or Bacteria
Isabelle Bekeredjian-Ding, Paul-Ehrlich Institut
How to handle Spreader Bacteria
Marcel Goverde, MGP
What is the spreading phenomenon?
How many CFUs are needed to spread?
How can spreaders be inhibited?
Common failure observed during autoclave and sterilization validation and routine monitoring – case studies
Walid El Azab, Steris Corporation
Discuss the top microbiological considerations when validating, requalifying and routine use of steam sterilization.
Impact of the different regulatory updates (EMA and future Annex 1 guidance) from an end-user perspective.
Common mistakes and lessons learned regarding steam sterilization autoclaves including Steam in Place (SIP) systems using case studies
New Data for MuScan Validation
Next generation sequencing (NGS) and microbiological quality control
Elena Bolchakova, Thermo Fisher Scientific
Viral detection with massive parallel sequencing of the amplified viral genomic tags
Benefits of MPS or NGS
Possible Challenges like host cell background
Workshop: Data Integrity in Microbiology
This workshop will cover the regulatory requirements and present approaches and practical experiences on the implementation of data integrity strategies in microbiological laboratories. It will provide you the possibility to discuss the challenges of the ongoing automation of methods and processes in relation to the increasing requirements of data integrity.
Even Data Integrity is one of the basic GMP principles. Multiple Data Integrity issues were reported by FDA und European inspectors during the last 3 years. Many US Warning Letters and EU Non-Compliance Reports deal with serious Data Integrity violations. Data Integrity questions have been and will continue to be the focus of many GMP inspections.
As a consequence, international authorities – FDA, EMA, PIC/S, WHO, MHRA - published draft documents to describe the regulatory expectations of Data Integrity.
Even though the guidelines are not intended to impose additional regulatory burden upon the regulated companies, a lot of uncertainty predominates the pharmaceutical industry about how to implement these requirements into the daily business.
Microbiological laboratories are influenced by these developments,as well.
All persons which will be involved in collecting, analysing and trending data in microbiological laboratories and will be challenged by the lab data integrity requirements. Additionally, all persons from QC and QA who have to judge these data for risk evaluation or release questions.
Requirements on Data Integrity in Laboratory
Gerald Kindermann, F. Hoffmann-La Roche, Switzerland
Life cycle approach for qualification of computerized systems in microbiological testing
Dr. Antja Motzek, Labor L+S AG, Germany
Data Integrity – Challenges in Microbiology
Di Morris, GSK, United Kingdom
Importance of Data Integrity when Testing for Endotoxin
Robert Porzio, Lonza, USA
Risk Assessment Strategies
Youwen Pan, Genentech, USA