Determining the Source of Contaminants and Foreign Particulate Matter in a Pharmaceutical Manufacturing Process

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Original Event Date: Tuesday, October 30, 2012
Duration:
 1 hour
Presenters:
David Exline, Senior V.P. and Antonio Scatena, Laboratory Manager at Gateway Analytical

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.

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

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.

Antonio Scatena

Laboratory Manager at Gateway Analytical

Antonio Scatena

Antonio Scatena has more than two years of forensic and pharmaceutical laboratory experience working within a cGMP and ISO-based quality assurance environment. As the Laboratory Manager at Gateway Analytical, Antonio executes the day-to-day technical operations in the lab, liaises with clients and serves as their scientific resource.

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. Antonio’s experience also includes materials characterization by means of high -resolution microscopy.

Antonio is a member of The American Association for the Advancement of Science and the American Chemical Society.