Sterilization and Sterility Assurance (Live Webcast)

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.