Event
Course Description:
This course offers participants a comprehensive insight into compendial (USP) microbiological quality requirements in the context of sterile products, while also discussing best practices for a microbiology laboratory and common compliance issues related to USP microbiology requirements. The following USP General Chapters are covered: <51>, <71>, <1227>, <85>, <151>, <1211>, <1229>, <1228>, <1117>, <1119>, and <1119.1>.
Upon completion of this course, you will understand:
- Describe the role of USP in microbiology and sterility assurance.
- Understand antimicrobial effectiveness tests, sterility tests, bioburden monitoring, and 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.
- Explain the use of different microbial enumeration methods for bioburden testing.
- Identify bioburden testing procedures and associated tests, such as the Growth Promotion Test.
- Participate in the USP standards-setting process.
Who Should Participate:
- QA/QC staff
- R.A. managers
- Scientists
- Investigators
- Other professionals who work or interact in a pharmaceutical microbiology laboratory environment