Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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 should you 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: