Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters is a seminar that covers topics such as:
- 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
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters brings together:
- Manufacturing
- Product Development
- Project Management
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Regulatory Compliance