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Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters

 

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About The Event

The objective of this two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn which are available and to confirm that those that you are using are being used correctly. USP documents that will be reviewed include:

  • USP<51> Antimicrobial Effectiveness Testing
  • USP<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
  • USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
  • USP<71> Sterility Tests
  • USP<1072> Disinfectants and Antiseptics
  • USP<1111> Microbiological Examination of Nonsterile Products
  • USP<1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products
  • USP<1113> Microbial Characterization, Identification, and Strain Typing
  • USP<1116> Microbiological Control and Monitoring of Aseptic Processing Environments

Various team exercises will be conducted to allow the participants to use these USP documents to solve "real life" problems. Plan to bring a cross-functional group of your personnel to attend this invaluable two day seminar.

Learning Objectives:

  • Understanding the various General and General Information USP Chapters that apply to microbiology
  • The focus of the chapters to include those that primarily involve non-sterile and sterile applications
  • Chapters that involve the environment
  • Examining the changes within the various Chapters that have recently occurred and how to interpret them
  • Review areas that are often overlooked
  • Study issues that continue to exist between the USP, EP and JP (harmonization)
  • Examine the new regulatory attitude that is occurring with non-sterile products
  • What now constitutes a "specified" and "objectionable" microorganism
  • Explore Form FDA 483s and Warning Letters for microbiological applications
 

Who Will Benefit:

  • Manufacturing
  • Product Development
  • Project Management
  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Regulatory Compliance

For More Info:

https://www.complianceonline.com/usp-microbiology-chapters-general-and-information-microbiology-raw-material-api-hvac-ep-jp-seminar-training-80241SEM-prdsm?channel=meraevent

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