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AES - Chemunex, Inc. Interactive webinar discussing: Improved methods for the early detection and enumeration of microorganisms in products; Getting faster results and reducing costs with viability-based technologies (rapid methods, results within hours) vs. traditional sterility tests (results after 14 days); Traditional sterility test methods will be compared to new technologies such as ScanRDI by AES-Chemunex; FDA guidelines for rapid methods; Strategies for dealing with sterility test positives; Conducting contamination investigations (production errors versus lab errors, identification of specific contaminants); Improving risk management. |
Rapid Microbiological Methods & Sterility Testing |
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AES - Chemunex, Inc. Interactive webinar discussing: The limitations of working manually in the micro lab; Sample preparation: approximations, errors, time-consuming; Media preparation and dispensing: homogenization of the sterilization process, maintaining media fertility, time-consuming, space-consuming, etc.; Temperature monitoring and recording: time-consuming, retroactive, etc.; The benefits of implementing automated methods: time-saving, precision, standardization, traceability, etc. |
How to Automate Your Lab |
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AES - Chemunex, Inc. Duration: 1 hour Donald Schaffner, Rutgers University Pascal Yvon, AES-Chemunex, Inc. Rick Biros, Carpe Diem Communications |
Challenges in Implementing HACCP |
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AES - Chemunex, Inc. Microbiological agents in manufacturing environments may compromise product sterility and functionality. Quantifying the presence of and exposure to airborne biological agents is critical to a company’s quality control program. The success of an air-monitoring program often rests on the proper selection of an air sampler and sampling technology. This presentation will evaluate the advantages and disadvantages of sampling technologies including impaction, impingement, filtration and electrostatic precipitation. Also critical to accurate air monitoring is the proper selection of sampling parameters (time, media, cut-off size, d50 etc.). This presentation will provide practical strategies and tactics to help your company optimize its air-monitoring program and help you answer questions |
Critical Strategies for Sampling Airborne Microbial Agents |
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AES - Chemunex, Inc. In recent years there has been an increased awareness on the topic of viable but not culturable cells. While this term is widely discussed, the science behind this phenomenon is not well known. As such, it becomes hard to evaluate the scientific and medical significance of this phenomenon. This talk will provide an overview of available literature including: - What is a viable but not culturable cell? - What causes a cell to enter this state? - What is the significance of VNBCs? - Why should I be concerned about them? |
Viable but not culturable cells - Why is there a concern? |
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AES - Chemunex, Inc. This webinar will serve as an introduction to the practical application of predictive microbiology tools to support HACCP decision making. The webinar will include both a scientific perspective on predictive microbiology as well information on how FDA and USDA view the use of modeling to support HACCP decision making. A brief overview of some of the commonly used model tools like the Pathogen Modeling Program, ComBase Growth Predictor, and the Integrated Lethality Spreadsheet will be presented. |
Use of Predictive Microbiology to Support HACCP Decision Making |
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AES - Chemunex, Inc. Is it the Next Step After HACCP? Microbial risk assessment in foods is one of the fastest changing areas in food microbiology. It is also of critical importance to global food safety and international trade. This webinar will provide an overview of this dynamic field, and provide an introduction to the topic suitable for beginners. Key issues: - What is quantitative risk assessment (QRA)? - How can QRA be applied to foods? - How is QRA being used by regulatory agencies today? |
Quantitative Risk Assessment |
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Almac Pharma Services Almac Pharma Services’ VP of Quality highlights the quality and regulatory considerations when launching drug product into Europe; the challenges faced by non-EU companies and the key requirements for releasing imported drug products into Europe. |
The Launch of commercial product into Europe by non-EU companies |
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Baxter Healthcare Corp. Execution at every step of the drug development process is crucial to your efforts to get to market on time. Replay our webinar presented by recognized experts with over 60 years of combined experience in fundamentals, application, and optimization of freeze-dried formulations and processes. |
Perfecting the Pass – Best Practices in Lyophiliza |
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