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

  • ID: 3785243
  • Webinar
  • 60 Minutes
  • Online Compliance Panel
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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.

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?

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.
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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.

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  • Compliance Manager
  • Process Engineer
  • Validation Manager
  • Regulatory Manager
  • Quality Control Scientists
  • Development Scientists
  • Production Management
  • Quality Assurance
  • Microbiologists
  • R&D Groups
  • Chemical Engineers
  • Production Supervisors
  • Chemists
  • Equipment Maintenance
Note: Product cover images may vary from those shown
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