The PDA has just released the proposed agenda for their 5th Annual Global Conference on Pharmaceutical Microbiology. The conference will be held in Washington, DC on October 25-28, 2010. Below you will find an overview of sessions that will focus on rapid microbiological methods.
Monday, October 25, 2010
Monday Poster Session
Validation of Ruggedness and Robustness of the Automated RMM BacT/ALERT Dual-T Sterility Testing System per USP 1223 / EP 5.1.6 / PDA TR 33. Carolyn Beres, Scientist, BioMerieux, Inc
Milliflex Quantum: A Fluorescence-based Platform for the Rapid Detection of Contaminants in Filterable Products. Wayne Miller, Regional Marketing Manager, Millipore
Tuesday, October 26, 2010
Session B3 – New Technologies 1
Validation of the Bactiflow ALS for Sterility Testing of an Emulsion Product. Michele Brown, Associate Scientist, Alcon Laboratories (Invited)
Using a Novel qPCR Platform To Accelerate Pharmaceutical Microbiology Testing. Amelia G. Trait-Kamradt, Pfizer (Invited)
Implementation of a Rapid Endotoxin Detection System in a Manufacturing Environment. Geert Verdonk, PhD, Senior Research Scientist, Merck Sharp & Dohme Oss
Session B4 - New Technologies 2
MALDI-TOF for the Identification of Environmental Isolates. Sara Polson, Staff Scientist, R&D Department, Accugenix, Inc.
Evaluation of the Millipore Milliflex Quantum Rapid Detection System: An Internal Study of a Novel Rapid Method for Microbial Detection in Traditional Membrane Filtration Bioburden Assays. Kevin Luongo, QC Scientist II, Specialty/Biotechnology, Pfizer Inc.
Celsis Advance and Limit of Detection. Kathleen Alford, Senior Scientist, Alcon Laboratories (Invited)
Tuesday Poster Session
In Process Bioreactor Monitoring Implementing and Validation of Novel Rapid Methods for the Detection of Bacteria and Mycoplasma in Mamallian Cell Cultures. Wayne Miller, Regional Marketing Manager, Millipore
MALDI-TOF for the Identification of Environmental Isolates. Melissa Ruch, Sales Support Leader, Accugenix, Inc.
Wednesday, October 27, 2010
Session P6 - Global Regulatory Perspective on RMM
Speakers from the FDA, TGA and PMDA are invited.
Session P7 – Compendial Challenges with RMM
Open discussion session on the role of the compendia in facilitating the implementation of these alternate technologies.
Thursday, October 28, 2010
The PDA Training and Research Institute (PDA TRI) will host a new course on rapid micro methods that will complement the topics presented at this conference:
Rapid Microbiological Methods: Overview of Technologies, Validation Strategies, Regulatory Opportunities and Return on Investment. Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC.
Monday, October 25, 2010
Monday Poster Session
Validation of Ruggedness and Robustness of the Automated RMM BacT/ALERT Dual-T Sterility Testing System per USP 1223 / EP 5.1.6 / PDA TR 33. Carolyn Beres, Scientist, BioMerieux, Inc
Milliflex Quantum: A Fluorescence-based Platform for the Rapid Detection of Contaminants in Filterable Products. Wayne Miller, Regional Marketing Manager, Millipore
Tuesday, October 26, 2010
Session B3 – New Technologies 1
Validation of the Bactiflow ALS for Sterility Testing of an Emulsion Product. Michele Brown, Associate Scientist, Alcon Laboratories (Invited)
Using a Novel qPCR Platform To Accelerate Pharmaceutical Microbiology Testing. Amelia G. Trait-Kamradt, Pfizer (Invited)
Implementation of a Rapid Endotoxin Detection System in a Manufacturing Environment. Geert Verdonk, PhD, Senior Research Scientist, Merck Sharp & Dohme Oss
Session B4 - New Technologies 2
MALDI-TOF for the Identification of Environmental Isolates. Sara Polson, Staff Scientist, R&D Department, Accugenix, Inc.
Evaluation of the Millipore Milliflex Quantum Rapid Detection System: An Internal Study of a Novel Rapid Method for Microbial Detection in Traditional Membrane Filtration Bioburden Assays. Kevin Luongo, QC Scientist II, Specialty/Biotechnology, Pfizer Inc.
Celsis Advance and Limit of Detection. Kathleen Alford, Senior Scientist, Alcon Laboratories (Invited)
Tuesday Poster Session
In Process Bioreactor Monitoring Implementing and Validation of Novel Rapid Methods for the Detection of Bacteria and Mycoplasma in Mamallian Cell Cultures. Wayne Miller, Regional Marketing Manager, Millipore
MALDI-TOF for the Identification of Environmental Isolates. Melissa Ruch, Sales Support Leader, Accugenix, Inc.
Wednesday, October 27, 2010
Session P6 - Global Regulatory Perspective on RMM
Speakers from the FDA, TGA and PMDA are invited.
Session P7 – Compendial Challenges with RMM
Open discussion session on the role of the compendia in facilitating the implementation of these alternate technologies.
Thursday, October 28, 2010
The PDA Training and Research Institute (PDA TRI) will host a new course on rapid micro methods that will complement the topics presented at this conference:
Rapid Microbiological Methods: Overview of Technologies, Validation Strategies, Regulatory Opportunities and Return on Investment. Michael J. Miller, Ph.D., President, Microbiology Consultants, LLC.