Use of Detectability In Risk Assessments

ValSource announced Quality Risk Management and Microbiology Consultant Amanda Bishop McFarland has been published by the Institute of Validation Technology (“IVT”) Network. IVT Network is a trusted source for life science validation and compliance professionals to access the most current and relevant industry and regulatory knowledge. McFarland’s article, “Considerations Regarding the Use of Detectability In Risk Assessments,” explores potential pitfalls associated with considering detectability within the risk management framework.

“The purpose of considering detection in any scenario is to ensure that potential or actual failures can be identified with enough time to take action before the user is adversely affected,” she said. “In the absence of knowledge management and a science­ and risk­ based rationale supporting monitoring programs, undue emphasis may be placed on implementing detection controls rather than directing resources towards preventing failure in the first place.”

McFarland specializes in the creation and implementation of Risk Management programs and in developing risk-based strategies for use in Microbiology. In 2015, she presented at the IVT’s Quality Risk Management Series and IVT’s Microbiology Week. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology, both from the University of Florida. Amanda is an active member of the Parenteral Drug Association (“PDA”) and a faculty member of the PDA’s Quality Risk Management and Risk-Based Qualification of Sterile Drug Product Manufacturing Systems training series. Her article for IVT Network was co-written with Kelly Waldron and available at http://www.ivtnetwork.com/article/considerations-regarding-use-detectability-risk-assessments.