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

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

Who Will Benefit:

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