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Conference Documentation: Pharmaceutical Microbiology

Conference Documentation: Pharmaceutical Microbiology Pharmaceutical microbiology is of crucial importance to the development and manufacture of pharmaceutical drugs, biologics and devices. Set to take place on the 21st and 22nd January 2015, the event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology

Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Hear presentations from the heart of industry, addressing real world case studies on the benefits and challenges of rapid methods, risk assessments and objectionable organisms. Share the wisdom of respected consultants and get the regulators perspective on recent changes and issues under review.


Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas
9:10
Relating microbial risk assessment to HACCP
Stephen Rawling, Microbiology Team Leader, GlaxoSmithKline
9:50
Stressed and objectionable microorganisms – how they impact us and how we impact them
Thomas Schwartz, Microbiology & Molecular Biology Group Leader, Forschungszentrum Karlsrube Gmbh
10:30
Morning Coffee
11:00
Profound risk assessment using Hazard Analysis and Critical Control Point to control biologic contamination during manufacturing of biologic products
Ruth Daniels, Head of MSAT Microbiology, Genzyme Flanders N V / S A
11:40
Latest approaches to preventing biofilms in water systems
Robert Neri , Senior Scientist, Sanofi
12:20
Networking Lunch
13:30
Twelve lessons learned on sterility assurance
Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas
14:10
Assessment of microbial risk to patients from aseptically manufactured products
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca PLC
14:50
Afternoon Tea
15:20
Development and management of sterilisation and validation processes
Jeanne Moldenhauer, Vice President, Excellent Pharma Consulting Inc
16:00
Implementing rapid microbiology methods
Andrew Bartko, Research Leader, Battelle Memorial Institute
16:40
Chairman's Closing Remarks and Close of Day One
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Olivier Chancel, Sterility and Aseptic Process Assurance Expert , Merial Sas
9:10
Mould contamination in pharmaceutical drug products
Phil Duncanson, Director, QC Microbiology, MedImmune
9:50
DNA-sequencing based methods: Is it really possible to use them for a rapid, efficient and routine-based microbial identification in pharmaceutical industry?
Sara Gamberini, Molecular Biology Scientist, Merck Serono - RBM
10:30
Morning Coffee
11:00
Latest technologies to combat and prevent water contamination and mould contamination
Brian Hubka, CEO, BGH International
11:40
Conducting an endotoxin sample storage study in biologics manufacture
Lada Laenen, Head of MSAT Cell Culture and Microbiology, Genzyme
12:20
Networking Lunch
13:30
Supplier Education: From pitfalls to reliable quality
Hans Noordergraaf, Microbiologist, Abbott Biologicals
14:10
Endotoxin detection in biopharmaceuticals
Wolfgang Mutter, General Manager, Hyglos GmbH
14:50
Afternoon Tea
15:20
Bioburden control, cleaning and disinfection
Jim Polarine, Technical Service Manager, Steris Corporation
16:00
Chairman’s Closing Remarks and Close of Day Two

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