Original Event Date: Tuesday, May 14, 2013
Duration: 60 minutes
Presenters: David Exline, Senior Vice President & Rebekah Byrne, Scientist I at Gateway Analytical
Host: Shawn Wilhelm, Marketing Coordinator at Gateway Analytical
Highlighted Topics Covered:
- Identify commonly found contaminants in parenteral drug products
- How contaminants are introduced in the manufacturing process
- How to detect contaminants visibly and non-visibly
- Laboratory techniques used to identify contaminates
- Provide insight into terminology used when discussing parenteral contamination
- How to reduce the risk of further contamination and potentially save money by taking a pro-active approach to quickly source and manage contaminant issues
During this webinar, our presenters identified commonly found contaminants in parenteral drug products, how these contaminants are introduced into the manufacturing process, how they can be detected both visibly and non-visibly and laboratory techniques used to identify contaminates. They provided insight into terminology used when discussing parenteral contamination including the difference between particle-free vs. sterile and the standards for visual inspection. They also discussed the importance of taking a pro-active approach to quickly source and manage contaminant issues in the manufacturing process to reduce the risk of future contamination and potentially save your company money by preventing potential recalls.
David Exline, Senior Vice President
David Exline has more than 18 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 Byrne, Scientist I
Rebekah has more than five years of experience working under quality systems in both clinical and analytical laboratory settings, including cGMP and ISO environments. Rebekah worked as a genetics scientist for two years before joining Gateway Analytical. She has worked specifically in materials characterization for about three years, with a focus on both pharmaceutical forensics and criminal forensics. She has helped develop professional courses for the pharmaceutical industry; additionally she has presented at the Mid-Atlantic Association of Forensic Scientists Annual Meeting.