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.
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤190.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤190.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤190.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤190.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤190.00 | View Details
Good Deviation Practice: What you Need to Know
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
Speaker: John R. Godshalk | View Anytime | Price: ¤190.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤390.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤390.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤390.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤390.00 | View Details
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.
Speaker: John R. Godshalk | View Anytime | Price: ¤390.00 | View Details
Good Deviation Practice: What you Need to Know
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
Speaker: John R. Godshalk | View Anytime | Price: ¤390.00 | View Details