Essentials Of USP Microbiology - For Those Who Are Not Microbiologists or Who Wish A Refresher

Topics

• The focus of the chapters to include those that primarily involve non-sterile and sterile applications and their interpretation
• The various General and General Information USP Chapters that apply to microbiology
• The changes within the various Chapters that have recently occurred and how to them
• An enhanced knowledge of the chapters that involve the microbial environment
• Issues that continue to exist between the USP, EP and JP (harmonization)
• Areas that are often overlooked or often misunderstood
• What now constitutes a "specified" and "objectionable" microorganism
• The new regulatory attitude that is occurring with non-sterile products
• Form FDA 483s and Warning Letters for microbiological applications

Who should Attend

Attendees with responsibilities in:

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