Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: John R. Godshalk

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 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:
– 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

SPEAKER PROFILE:
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.