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Essentials of Microbiological Testing

Course Information:

Course Description:

This course establishes a practical understanding of microbiological practices in the pharmaceutical industry and provides an overview of the USP General Chapters which address microbiological testing. Next, selection of elective topics are picked for discussion based on the needs of the students.

Who Should Attend:

This course is intended for those who directly work in the microbiology lab, or interact with those who do.


1 Day

Learning Objectives and Course Outline:

Learning Objectives
  • At the conclusion of this course, the participant should have an understanding of:
  • The nature of microbiology
  • Metabolism and environmental requirements
  • Taxonomy and identification
  • Best lab practices
  • Variability of microbiological data
  • Overview of microbiological testing General Chapters in the USP-NF:
  • <51> Antimicrobial Effectiveness Testing
  • <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
  • <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms
  • <1111> Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
  • <1112> Application of Water Activity Determination to Non-Sterile Pharmaceutical Products

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