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 Requirements
Instructor: John R. Godshalk
Product ID: 501637
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
  • 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
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.

Who will Benefit
  • Compliance Manager
  • Process Engineer
  • Validation Manager
  • Regulatory Manager
$375
Recorded Session for one participant
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  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
John currently works for the Biologics Consulting 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 and guidances. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and cGMP compliance 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.


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