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: ¤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

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

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

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