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Webinar Event:
Determining the Source of Contaminants and Foreign Particulate Matter in a Pharmaceutical Manufacturing Process
Event Date: Tuesday, October 30, 2012
Time: 1 p.m. EDT
Duration: 1 hour
Presenter: David Exline, Senior V.P. and Antonio Scatena, Lab Manager, at Gateway Analytical
Highlighted Topics Covered
- The process for isolating contaminants and foreign particles
- The process for identifying foreign particles
- The process for finding the source of the contaminate
Webinar Overview:
When contaminants or foreign particulate matter arise in a pharmaceutical manufacturing process, the FDA requires a full investigation to identify the material and determine where it has come from. However, determining the source of these materials may not be straightforward.
This webinar is designed for laboratory and manufacturing personnel that encounter contaminants and foreign particulate matter in the manufacturing, process/product development and customer returns. This webinar will discuss the process by which contaminants and foreign particles are isolated, identified, tracked to find the source of the issue, and then addressed to ensure that the issue does not arise again.
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About the Presenters
David Exline, Senior V.P.
David Exline has more than 15 years of experience in managing and administering analytical laboratory and consulting services and has helped many companies establish cGMP laboratories and assisted pharmaceutical drug manufacturers to ensure that their cGMP facilities are compliant with FDA regulations.
Antonio Scatena,
Lab Manager
Antonio is well versed in the identification and characterization of foreign particulate using a variety of analytical instruments and routinely performs comparative analyses to determine the potential sources of contamination.
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