Course Description: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.
The live version of this recording took place on February 12, 2020.Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first. The accompanying USP General Chapter(s) available as resources with this on-demand course, were official as of this date. Please check www.uspnf.com for relevant updates.
Upon completion of this course, you will understand:
- 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
USP Approved Instructor
Dr. Radhakrishna S. Tirumalai
Senior Scientist, USP
Ph.D., biochemistry, 1988, University of Mysore, Mysore, India