Lyophilization: What you Need to Know, Validation and Regulatory Approaches

Overview:

This webinar 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 seminar 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.

Why you should Attend:

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.

Areas Covered in the Session:

• Science of Lyophilization
• Cycle development and tools
• Validation of the Lyo Cycle
• Lyo equipment validation
• Regulatory requirements
• How the lyo process and equipment are inspected
• The science and the art

Who Will Benefit:

• Compliance Manager
• Process Engineer
• Validation Manager
• Validation Engineer
• Regulatory Manager