The regulatory environment regarding controlled temperature storage of Life Science product is changing quickly. New or revised regulations have been released in India, Europe, Canada, and the USA recently. These changes increase the breadth of the supply chain that is regulated. In short, more players need to show compliance, and they need to do a thorough job of it.
In this webinar, our Senior Regulatory Expert Paul Daniel shows you techniques to assess risk in GxP environmental monitoring systems. These tools will allow you to more accurately determine the validation requirements of computerized systems and make your software validation workload more manageable. Paul also discusses how to justify your methods with appropriate rationales. View presentation slides.
Key Learning Objectives
- Introduction to risk assessment methods and techniques
- Understand the process and goals of assessing risk
- Show examples from Vaisala Continuous Monitoring System
- Regulatory Managers
- Metrology Managers
- Quality Managers
- Validation Managers
- Facility Managers
- Stability Managers
- Warehouse Managers
- Laboratory Managers
- Logistics Managers
- R & D Managers
Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.
At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.
Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.