Event
This two-day course will offer participants a comprehensive insight into compendial (USP) microbiological quality requirements in the context of Sterile Products vis a vis USP General Chapters <51>, <71>, <1227>, <85>, <151>, <1211>, <1229>, <1228> and <1117>, while also discussing the best practices in a microbiology laboratory and common compliance issues related to USP Microbiology requirements.
By taking this course, you will be able to:
- Describe the role of USP in microbiology and sterility assurance
- Understand antimicrobial effectiveness tests, sterility tests, pyrogen and bacterial endotoxin tests
- Define sterility assurance, sterilization, aseptic processing and depyrogenation
- Describe laboratory best practices in microbiology and common compliance issues to avoid
- Participate in the USP standards-setting process.
Who Should Participate:
- QA/QC staff
- RA managers
- Scientists
- Investigators
- Other professionals who work or interact in a pharmaceutical microbiology laboratory environment.