Download Our Webinar: “From Detection to Investigation: Know Your Product’s Connection with FPM”


In case you missed it, I recently teamed up with Carol Whitinger of SoloHill Engineering to present a free webinar on Foreign Particulate Matter (FPM) entitled, “From Detection to Investigation: Know Your Product’s Connection with FPM.”  I want to invite you to download a copy of the webinar, in case you were unable to attend or you attended and would like a copy.  You can download it now at the bottom of this post.

When you watch this webinar, you will learn:

  • Pros and cons of visual inspection methodologies
  • Understanding of Particle Validation Standards (PVS) for training manual inspectors and their role in validating automated inspection equipment
  • Sources of FPM and root cause determination strategies
  • Strategies for establishing a proactive FPM management program

After learning this information, we share two case studies that show the previously presented methods in everyday practice.  The first case study looks at a foreign particle found in a parenteral product — showing how it was detected, categorized, and ultimately characterized.  The second case study explores contaminated products found in 10 lots of a raw material.  It demonstrates how using a mixed method approach and having an established particulate program can aid in efficient, cost effective investigation.

Watch the FREE Webinar Now!




Karen Smith

About Karen Smith

Karen Smith is a senior scientist RJ Lee Group, specializing in the identification and characterization of foreign particulate matter (FPM), as well as root cause failure analysis investigations for the life science industry. This expertise appropriately extends to assisting clients in developing proactive measures to manage their FPM issues. Since joining RJ Lee Group in 2008, she has frequently led training courses and presented at seminars for FPM identification. Ms. Smith works closely with clients on contaminant source analysis by interpreting and reporting data. Karen has a keen eye for detail and precision, making her a multi-faceted scientist in failure analysis and overall process methodology.

Contact Karen Smith


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