This Event has Passed
Thursday, October 07, 2021
6:00 AM - 12:00 PM
6:00 AM - 12:00 PM See all dates and Times
Virtual Event
The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are used correctly. USP documents that will be reviewed include:
USP<51> Antimicrobial Effectiveness Testing
USP<60> Microbiological Examination of Nonsterile Products Tests for Burkholderia cepacia Complex
USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
USP<71> Sterility Tests
USP<85> Bacterial Endotoxins Test
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
USP<1227> Validation of Microbial Recovery from Pharmacopeial Articles
Learning Objectives:
Understanding the various General and General Information USP Chapters that apply to microbiology
Study the focus of the chapters to include those that primarily involve non-sterile and sterile applications and their interpretation
Gain an enhanced knowledge of the chapters that involve the microbial environment
Examining the changes within the various Chapters that have recently occurred and how to interpret them
Review areas that are often overlooked or often misunderstood
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
