Lyophilization: What you need to Know, Validation and Regulatory Approaches
Duration: 60 Minutes
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More and more of today's (and tomorrow's) drugs are biotech drugs, complex and often highly sensitive molecules. External factors such as oxygen, sunlight, and pH values can negatively affect biotech products, leaving marketers looking for innovative ways to protect and preserve these important compounds until they can be administered to patients. The lyophilization process can protect biological activity, extend shelf life, and even increase dosing precision. In recent years, more than 30% of parenteral Food and Drug Administration (FDA) approvals were for lyophilized drugs, and estimates predict that soon more than half of all injectable drugs will require lyophilization.
05/11/2018 10:00 AMTraining Topic: Lyophilization: What you need to Know, Validation and Regulatory ApproachesInstructor: John R. Godshalk
Objectives of the Presentation
Science of Lyophilization
Cycle development and tools
Validation of the Lyophilization Cycle
Lyophilization equipment validation
How the Lyophilization process and equipment are inspected
The science and the art
Why Should you Attend
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.
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.