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

  • ID: 3786481
  • Webinar
  • 60 Minutes
  • NetZealous LLC
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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
Note: Product cover images may vary from those shown
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- 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
Note: Product cover images may vary from those shown
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  • John R. Godshalk John R. Godshalk,
    Sr Consultant ,
    Biologics Consulting


    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.

Note: Product cover images may vary from those shown
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  • Compliance Manager
  • Process Engineer
  • Validation Manager
  • Validation Engineer
  • Regulatory Manager
Note: Product cover images may vary from those shown
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