Speaker Profile


John R. Godshalk

Senior Consultant, Biologics Consulting Group, LLC

John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. He 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.

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  • Recorded
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  • $190.00
Good Documentation Practice for GxP Environments

This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

  • Recorded
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  • $190.00
Lyophilization: What you Need to Know, Validation and Regulatory Approaches

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.

  • Recorded
  • View Anytime
  • $190.00
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.

  • Recorded
  • View Anytime
  • $190.00
Good Documentation Practice for GxP Environments

This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.

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161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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