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

Key Topics

• 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
• The changes within the various Chapters that have recently occurred and how to interpret them
• Areas that are often overlooked
• Issues that continue to exist between the USP, EP and JP (harmonization)
• New regulatory attitude that is occurring with non-sterile products
• What now constitutes a "specified" and "objectionable" microorganism
• Form FDA 483s and Warning Letters for microbiological applications

Who should Attend

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