Essentials of Control and Testing of Microbial Quality of Nonsterile and Sterile Products (Classroom)

Event

Course Description
This two-day course provides an in-depth understanding of microbiological practices in the pharmaceutical industry and gives an overview of the USP General Chapters that address microbiological testing, validation of microbiological methods and Sterilization, e.g. USP General Chapters <61>, <62>, <71>, <85>, <1111>, <1112>, <1115>, <1116>, <1117>, <1227>, <1229>, Variability in Plate Count Methods, etc.

After completing the course, the attendee will be to understand or refresh and interpret

  • 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 Tests and Acceptance Criteria for Microbial Quality of Non-Sterile Pharmaceutical Products, Sterility Tests and Sterility Assurance, Bacterial Endotoxins Test, Bioburden Control in Nonsterile Drug Substances and Products, Contamination Control and Monitoring in Aseptic Manufacturing Environments
  • Validation and Verification of Compendial Microbiology Tests
  • Best Lab Practices in Microbiology
  • Participate in the USP- Standard Setting Process

    •  
    Who Should Participate:
    This course will benefit Q.A, Q.C, R.A Managers, Scientists, Investigators and other professionals who work or interact in a microbiology environment in Pharmaceutical, Biotech, Excipients or Allied Industries.

    Register now