Laboratory Methods for Failure Analysis of Pharmaceutical Products

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Original Event Date: Wednesday, November 14, 2012
 1 hour
David Exline, Senior V.P. and Rebekah Wagurak, Forensic Scientist at Gateway Analytical

Failures in pharmaceutical products may range from issues with delamination and  packaging failures to polymorphs arising in the pharmaceutical product.This webinar is designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This webinar discusses case studies and walks participants through the process of investigation, common methods used, and interpretation of analytical data to improve overall process development and quality control.

Highlighted Topics Covered
    • Case studies on packaging failures
    • The process of investigation for failure analysis
    • Most common methods used for package testing
    • The interpretation of analytical data to improve overall process development

Replay Webinar

Presenter Bios:

David Exline
Senior V.P. at Gateway Analytical
David Exline

David Exline

David Exline has more than 15 years of experience in managing and administering analytical laboratory and consulting services. Mr. Exline has helped companies establish cGMP laboratories and assisted pharmaceutical drug manufacturers to ensure that their cGMP facilities are compliant with FDA regulations. He is adept in numerous pharmaceutical-related services and testing methods including: materials characterization, particulate contamination analysis, particle sizing and high-resolution microscopy.

Although familiar with analytical practices in several industries, Mr. Exline’s expertise lies in the pharmaceutical, materials science and forensic realms.

Rebekah Wagurak

Rebekah Wagurak

Rebekah Wagurak
Forensic Scientist at Gateway Analytical

Rebekah Wagurak has several years of experience working under quality systems in both clinical and analytical laboratory settings, including cGMP and ISO environments. She has over two years of experience in materials characterization for both the forensic and pharmaceutical industries. Rebekah is well-versed in troubleshooting, customer interfacing, and method development.