RJ Lee Group Provides Training to the U.S. FDA on Managing Foreign Particulate Contamination in Pharmaceuticals


(MONROEVILLE, Pa., September 28, 2012) Members of RJ Lee Group, Inc.’s Biotechnology and Pharmaceutical Services Department conducted a training seminar for U.S. Food and Drug Administration (FDA) field inspectors entitled “Managing Foreign Particulate Investigations.”  The seminar, presented by forensic scientists Ms. Karen Smith, Ms. Julia Patterson, and Mr. Michael Gorski, focused on proactive measures for addressing foreign particulate matter (FPM) contamination in pharmaceutical products by using an industrial forensics approach to collect, isolate, classify, and characterize the particles.

“FPM contamination is gaining recognition as a problem in the pharmaceutical industry,” explained Biotechnology and Pharmaceutical Services manager Julianne Wolfe.  “We appreciate the FDA’s interest in our technology and the opportunity to assist in their proactive FPM investigations.”

In response to increasing concerns about FPM, pharmaceutical organizations and manufacturers have been developing programs to investigate and prevent foreign particulate contamination.  RJ Lee Group conducts seminars at various institutions and manufacturing sites to help with understanding, establishing, or enhancing such programs.

About RJ Lee Group

RJ Lee Group is an industrial forensics laboratory that is recognized as a leader in providing innovative solutions to challenges in materials characterization, forensic engineering, and information management. For 30 years, we have been using our scientific expertise, instrumentation and technology to offer support strategies and provide solutions to our customers. RJ Lee Group is a 300-person company with headquarters located in Monroeville, PA. For more information visit our website at www.rjleegroup.com.

Leave a comment