Agenda released - Pharmaceutical Microbiology 2019 announces key
SMi is proud to announce the 8th Annual Pharmaceutical Microbiology is back and this year the conference is taking place at the Copthorne Tara Hotel in London, UK on 21st and 22nd January 2019.
Sponsored by: Gold Sponsor: DuPont and Sponsors: Mettler Toledo, Biomerieux and Copan Group
Proud to announce the Co-Chairs for the conference James Drinkwater, Chairman, Pharmaceutical & Healthcare Sciences Society and Olivier Chancel, Sterility, and Aseptic Process Assurance Expert, Boehringer Ingelheim
James Drinkwater, Chairman, Pharmaceutical & Healthcare Sciences Society
James Drinkwater is Head of Aseptic processing technologies & GMP compliance for Franz Ziel Germany, supporting international projects from a base in the UK. As a subject matter expert in Barrier separation technology; Isolator / RABS and hydrogen peroxide vapour bio-decontamination, James is involved in applications of sterile pharmaceutical product Filling, Aseptic processing of APIs/ ATMPs and Sterility testing. In addition to the role at F Ziel James has a voluntary role as Chairman of the not for profit society: PHSS – Pharmaceutical and Healthcare sciences society and leads the PHSS Aseptic processing & Bio-contamination special interest group.
Olivier Chancel, Sterility, and Aseptic Process Assurance Expert, Boehringer Ingelheim
Doctor Pharmacist, graduated in technological pharmacy, quality control and management. Currently Sterility and Aseptic Practice Assurance Expert and formerly Head of Performance and Pharmaceutical Support in Boehringer Ingelheim, Toulouse, France. Provide a corporate support on sterility and aseptic processes to Boehringer Ingelheim Animal Health sites. Used to work in or with the pharmaceutical industry for 15 years at various positions including pharmaceutical research and development, Quality Assurance, Quality Control, project management and production for both solid and injectable dosage forms.
Key Expert Speakers include:
Alexander Stoll, VP Competence Center Microbiology & Aseptic Technique Quality Management, Fresenius Kabi
Alexander from Germany always had a high interest in the field of molecular biology and he completed his PhD thesis in Microbiology/Genetics during September 2001 at the University of Kaiserslautern. After moving to Sweden, he started working in December 2001 for Fresenius Kabi sterile international manufacturing plant in Uppsala, leading a group of microbiologists responsible for microbiological qualification of sterilization processes. Throughout the years Alexander has been holding different management positions for the Swedish manufacturing plants within Quality Control, Quality Assurance and as a Qualified Person. Starting 2012 he had responsibility as a Global Operations QA head, with regional QA and plant QA functions directly reporting to him. In his current position as Vice President Competence Center Microbiology & Aseptic Technique he has built a group of subject matter experts working with all pharmaceutical Fresenius Kabi manufacturing sites and compounding centers, setting global standards. Throughout the years he has gained intensive hands-on experience from different sterile manufacturing techniques for finished medicinal product & API and multiple international authority inspections.
Di Morris, Senior Manager, Team Leader, Vaccines Quality Audit, GSK
Di – MRSC Chemistry and PGDiPS and a Qualified Person under permanent provisions since 1993; Pharmaceutical industry for over 30 years/ a number of years as a Medicines Inspector for the MHRA. Di/worked in the areas of Quality Control (Chemistry and Microbiology), Quality Assurance and Regulatory Affairs/worked with a wide range of dosage forms including sterile products, biological, and non-sterile products.
Marine Marius, Scientist, Analytical Research & Development Europe, Sanofi Pasteur
Marine is Scientist in the Analytical Sciences department of Sanofi Pasteur in the Microbiology/Virology platform. She leads the development, validation and implementation of rapid microbiology methods (bacteriology and molecular biology) for legacy and investigational products. She is an internal SME in endotoxin, mycoplasma and mycobacteria testing. Marine holds a M.Sc. in Biotechnology and Applied Microbiology from ESIL University (Ecole Supérieure d’Ingénieurs de Luminy) in France.
Philippe Dutot, Sterility Assurance Specialist, Novo Nordisk
Philippe Dutot is Engineer in Biotechnology and he has a PhD in Molecular and Cellular Biology.
He has around 25 years of experience in biotech and pharmaceutical industries at different management and specialist positions in R&D, Scale-up of Production, Quality Control and Quality Assurance.
He is currently Sterility Assurance Specialist at Novo Nordisk Production – France in a facility dedicated to manufacture of aseptic products. He is also Corporate Lead Auditor for his company.
Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna
Renate’s career originated from science and research through her work in academia which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she is Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria.
Thierry Bonnevay, Microbiology Platform Head, Analytical Research and Development, Sanofi Pasteur
Thierry obtained his Pharm. D pharmacist with special degree in Industrial Pharmaceutical Microbiology in 1996. He joined Sanofi Pasteur in 1997 as QC Bacteriology manager in Industrial Operation. He joined the Analytical Research and Development Department in 2004 and since that time he worked in the development, the validation and the implementation of Microbiology alternatives methods based on bacteriology and molecular biology for commercialized products and clinical products. He is currently Microbiology Platform Leader in Analytical R&D and part of the USP expert panel in Modern Microbiological Methods (MMM) since 2015. He is member of Groups of Experts at the European Pharmacopoeia EDQM Group 1 Microbiology since November 2016 and Working Party Bacterial Endotoxin Test (WP BET) since November 2017.
Tim Eaton, Sterile Manufacturing Specialist, AstraZeneca
Tim B.Sc. (chemistry) has over 25 years’ experience of sterile manufacturing with Zeneca Pharmaceuticals and AstraZeneca. During this time he has had extensive roles in technical support, production management and specialist activities for aseptically prepared products. He has had responsibilities for the design, construction, start up and validation of multimillion pound aseptic manufacturing facilities and has managed the introduction, technical transfer and scale up activities for a number of sterile products. He has published a number of papers relating to cleanroom activities and has also presented at various industry forums in Europe, Asia and the US.
In his current role of Sterile Manufacturing Specialist he has responsibilities for the derivation, optimisation and implementation of best practices for aseptically prepared products. He sits on LBI/30, the British Committee for Cleanroom Technology.
To view the full speaker line-up and 2-day agenda please click on this link:
The conference also has 2 interactive half day post conference workshops, which provide extra value to the pharmaceutical microbiology conference, which are taking place on 23rd January 2018 at the same venue.
Morning Workshop A: Common Mistakes Made When Setting Up an Environmental Monitoring Programme
Workshop Leaders: Ziva Abraham, CEO, Microrite & Morgan Polen, Contamination Control and Cleanroom Expert, Microrite
Afternoon Workshop B: Rapid Microbial Methods & Developing a Risk-Based Cleaning and Disinfection Programme
Workshop Leaders: Andrew Bartko, Research Leader, Battelle Memorial Institute & Jim Polarine, Senior Technical Service Manager, Steris Corporation
If you are interested in participating and attending the conference, you can register at www.pharma-microbiology.com, and save £400.
Interested in sponsoring, exhibiting or speaking at this event?
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Pharmaceutical Microbiology 2019
21st – 22nd January 2019
Copthorne Tara Hotel. London, UK
Follow us @SMiPharm
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