Course Description:This course will offer participants a comprehensive insight into USP requirements for microbiology and sterility assurance in the context of 3 USP General Chapters, Evaluation of Aseptic Processing Environments, Sterility Assurance, and Sterilization. The chapters covered are the following:
- USP <1116> Microbiological Evaluation of Aseptic Processing Environments
- USP <1211> Sterility Assurance
- USP <1229> Sterilization of Compendial Articles
Upon completion of this course, you will be able to:
- Explain the role of USP in Microbiology and Sterility Assurance of compendial articles.
- Describe and apply different sterilization methods.
- Explain aseptic monitoring of clean rooms, design and qualification of clean rooms.
- Develop an environmental monitoring program given USP standards.
Who Should Participate:
- QA/QC staff
- Regulatory affairs managers
- Regulatory professionals
- Scientists
- Microbiologists
- Investigators
- Other professionals who work or interact in a pharmaceutical microbiology laboratory environment.
Access Duration:
Access to this course expires 6 months 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.
USP Approved Instructor
Vanessa Vasadi Figueroa
USP Consultant
Master’s Degree in Molecular Biology and Microbiology from San Jose State University