Event
Course Description:
This laboratory course focuses on the understanding and execution of USP General Chapter <81> Antibiotics-Microbial Assays using the current USP–NF microbiological assay procedures. The course introduces the general chapter and status followed by hands-on laboratory demonstration. Participants will utilize USP General Chapter <81> along with the appropriate USP Reference Standard to determine antibiotic relative potency. The required statistical tools, data analysis and the interpretation of antibiotic microbial assay methods will be applied during the lab.
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.
- Apply USP General Chapter <81> quality standards according to the chapter procedures.
- Demonstrate USP General Chapter <81> assay techniques and methods in a laboratory setting according to the chapter procedures.
Who Should Participate:
- Microbiologists
- Microbial Assay Scientists
- Regulatory Scientists
- Analytical Scientists
- QA & QC Staff
- R&D Scientists and Managers
- Contract Research Organizations