Event
Course Description:
This course focuses on the understanding of USP General Chapter <81> Antibiotics-Microbial Assays using the current USP–NF microbiological assay procedures. The course introduces the general chapter and current status. Participants will review the USP General Chapter <81> to identify the appropriate USP Reference Standard used to determine antibiotic relative potency. The required statistical tools, data analysis and the interpretation of antibiotic microbial assay methods will also be determined.
Upon completion of this course, you will be able to:
- Explain microbial assay methods used to measure antibiotic potency in USP General Chapter <81> Antibiotics- Microbial Assays
- Describe the purpose and approach of proposed USP General Chapter <426> Histamine Test Methods.
- Explain the purpose of USP General Chapter <1223.1> and the importance of bridging between a microbial bioassay and the HPLC method.
- Identify suitable approaches to modernizing USP monographs.
Who Should Participate:
- Microbiologists
- Microbial Assay Scientists
- Regulatory Scientists
- Analytical Scientists
- QA & QC Staff
- R&D Scientists and Managers
- Contract Research Organizations