ValSource Consultant Marsha Hardiman Presents on Environmental Monitoring
March 7, 2017
ValSource Senior Consultant Marsha Hardiman is a featured speaker at the Parenteral Drug Association (“PDA”) Southern California Chapter Aseptic Processing and Contamination Control Symposium. The
symposium takes place Thursday, March 14th at Crown Plaza Costa Mesa in Costa Mesa, CA. Hardiman presents the session: “Creating Your Monitoring Plan and Risk Assessment for ISO 14644-1 and 14644-2.” Marsha’s presentation addresses the changes to ISO 14644 Parts 1 and 2 and focuses on the factors to consider when performing risk assessment and creating a monitoring plan.
“Changes to these ISO standards will impact the way companies perform cleanroom classification activities,” Hardiman said. “Our strategies offer a clear path to compliance.”
Hardiman 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. Marsha has 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 Hardiman 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.