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