Microbiology and Sterility Assurance (Classroom)

Event

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.

Objectives:

In this course you will learn about:

  • 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