Event
This one day course will offer participants a comprehensive insight into USP requirements for microbiology and sterility assurance in the context of USP General Chapters <51>, <61>, <62>, <71>,
<1111>, <1115>, <1227>, Sterility Assurance, Sterilization and Best Laboratory Practices in microbiology.
Objectives:
In this course you will learn about:
- The role of USP in microbiology and sterility assurance
- Types of microbiology tests in the USP–NF
- Basics of growth-based compendial microbiology tests, including their variability
- Details of antimicrobial effectiveness tests, tests and acceptance criteria for microbial quality of non-sterile pharmaceutical products, bioburden control and objectionable organisms, Sterility tests, and Sterilization and Sterility Assurance
- Best lab practices in microbiology
- Participation in the USP standards-setting process
Who Should Participate:
- Quality assurance/quality compliance staff
- R.A. managers
- Scientists
- Investigators
- Regulatory professionals
- Other professionals who work or interact in a pharmaceutical microbiology laboratory environment