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Senior Consultant Marsha Steed is a featured speaker at the ECHO Consulting Group Educational Summit. The summit takes place Friday, August 18th at The Ritz Carlton in San Juan, Puerto Rico. Steed presents the session: “Microbial and Environmental Monitoring Risk Assessment.” Marsha’s presentation addresses microbial and Environmental Monitoring (“EM”) risk assessment tools and methods for all types of manufacturing processes:  aseptic processing, terminal sterilization, low bioburden and non-sterile.

Marsha“Contamination control begins with good design coupled with risk assessment and risk mitigation,” Steed said. “Our strategies ensure microbial risk assessments evaluate all materials and equipment used in the manufacturing process so that risks can be understood and mitigated when possible. Likewise, we encourage EM risk assessments be performed to ensure that EM sample locations are selected based on risk.”

Steed is a recognized expert in risk based Environmental Monitoring and microbiological contamination control with over 20 years of experience in the pharmaceutical and medical device industries with extensive experience in Quality and Microbiology. Her leadership experience includes global experience with manufacturing locations in North and South America, Europe and Asia. Marsha has strong quality auditing experience for requirements to FDA, EMEA, ISO and other national regulatory requirements. Her experience includes being a notified body inspector for ISO/CE marking. Marsha is actively involved in the PDA and is a member of the Scientific Advisory Board (SAB), the Education Advisory Board (EAB) and the 2017 Microbiology Program Planning Committee.

Marsha can be reached at mstabler@concordiavalsource.com.