A 1-hour training in five best practices for performing temperature mapping studies
The regulatory environment regarding controlled temperature storage of life science products is changing quickly. New or revised regulations have been released in India, Europe, Canada, and the USA. These changes have increased the breadth of the supply chain that is regulated.
Temperature mapping is a key strategy used in GxP-regulated environments to demonstrate the temperature uniformity necessary for safe storage of products. With new regulations, mapping studies are often performed (or reviewed) by people who are new to mapping. With more companies than ever needing to perform mapping studies to demonstrate understanding of their environments, it's more important than ever before to have clear guidelines and best practices for sensor placement.
This webinar teaches sensor placement in 5 simple rules. These rules are presented in a simple mathematical format that will allow anyone with limited experience with mapping studies to effectively determine proper sensor placement for a study. We will also discuss the regulations and recently published guidance to demonstrate suitability and relevance of the 5 rules.
If you are new to mapping studies, or if you train individuals unfamiliar with the practice, these rules are invaluable information for you...
Key Learning Objectives
- Review the global regulatory changes and guidance on GDP from: CFDA, EMA, USP36 Chapter <1079>, CDSCO, PDA, ISPE etc.
- Learn the "5 Rules" of mapping to ensure that storage spaces are controlled to meet specifications.
- Review the many factors that will impact sensor placement
- Undertand how to create an effective ratio of sensor to area for mapping
- Regulatory Managers
- Metrology Managers
- Quality Managers
- Validation Managers
- Facility Managers
- Stability Managers
- Warehouse Managers
- Laboratory Managers
- Logistics Managers
- R & D Managers