Lyophilization: What you Need to Know, Validation and Regulatory Approaches
Duration: 60 Minutes
This course explores the science and art of lyophilization and discusses how the lyophilization cycle and process is developed and validated, along with the regulatory requirements for lyophilization.
Lyophilization is complex and this webinar will break the process down so that it can be more easily understood. The important aspects of how FDA inspects and regulates the lyophilization process, equipment, and controls will be discussed. The science and art of how to develop lyophilization cycles will be discussed. Lyophilization controls, including computer controls and validation will be explored. Quality aspects of lyophilization including obtaining a resulting quality product will be discussed.
Objectives of the Presentation
Why Should you Attend
- Science of Lyophilization
- Cycle development and tools
- Validation of the Lyophilization Cycle
- Lyophilization equipment validation
- Regulatory requirements
- How the Lyophilization process and equipment are inspected
- The science and the art
The attendee will learn how lyophilization cycles are developed, how lyophilizers work and how they are controlled and what is important to FDA and other regulatory bodies in the inspection of lyophilizers and in the validation process.
Who will Benefit
- Compliance Manager
- Process Engineer
- Validation Manager
- Regulatory Manager