Poster: Mitigating human error in Environmental Monitoring Investigations
At the PDA Micro conference, our team presented a critical analysis on the role of human error in Environmental Monitoring (EM) and how modern digital solutions can reduce these errors.
The poster presentation begins by introducing the concept of human error, outlining its relevance in the highly regulated field of environmental monitoring. It demonstrates how human mistakes contribute to inefficiencies and non-compliance, with real-world examples drawn from FDA 483 observations.
What makes this presentation particularly insightful is the global survey data included in the poster, which paints a picture of common EM experiences and pain points from cleanroom professionals around the world. These survey results offer crucial context for the issues discussed, providing a clear understanding of why these topics are relevant to today’s pharmaceutical and cleanroom environments.
Additionally, the poster provides practical tools and strategies to help overcome the burden of human error in cleanroom EM processes. These strategies include leveraging digital automation to streamline workflows, understanding variables that affect human cognition, and establishing effective control measures. By implementing these solutions, companies can achieve better regulatory compliance, reduced risks, and more reliable production outcomes.
Our presentation emphasizes the power of digital platforms in mitigating these risks. By implementing automated systems, companies can significantly reduce human error, improve data accuracy, and streamline regulatory compliance. These advancements ultimately ensure safer drug production and enhanced operational efficiency.
Attendees at the PDA Micro conference had the opportunity to learn more about how our cutting-edge software solution can help optimize environmental monitoring processes, reducing human intervention risks and enhancing overall quality.
If you’d like to learn more about the role of human error in Environmental Monitoring, feel free to download our poster by filling out the form below.
For any questions or to discuss this topic further, don’t hesitate to reach out to us at info@sherpapharma.com
Having contributed significantly to industry leaders such as Lonza, Qiagen, Roosterbio, Emergent Biosolutions, and CBMG, Alex brings a blend of technical acumen with hands-on expertise. As a career QC scientist and growing compliance expert, she has consistently demonstrated a commitment to operational excellence and continuous improvement.
Alex holds an undergraduate degree in Biochemical Engineering from UMBC and a graduate degree in Biomedical Engineering from Clemson University. Beyond the laboratory, she brings a global perspective, having lived abroad in China, and is fluent in Mandarin Chinese. Alex also enjoys rock climbing and indulges in tabletop gaming.
Sarah Boynton is a recognized expert in biologics and Advanced Therapy Medicinal Products (ATMP) commercial manufacturing, specializing in Human and Organizational Performance (HOP). With over 15 years of experience, Sarah has held key roles in operations, deviation management, and training management, and has also served as a consultant for large organizations in these areas.
In addition to her professional career, Sarah is dedicated to mentorship and leadership development, currently serving as the Women in Bio Capital Region MAPS Chair, where she supports programs focused on women’s empowerment.
Having contributed significantly to industry leaders such as Lonza, Qiagen, Roosterbio, Emergent Biosolutions, and CBMG, Alex brings a blend of technical acumen with hands-on expertise. As a career QC scientist and growing compliance expert, she has consistently demonstrated a commitment to operational excellence and continuous improvement.
Alex holds an undergraduate degree in Biochemical Engineering from UMBC and a graduate degree in Biomedical Engineering from Clemson University. Beyond the laboratory, she brings a global perspective, having lived abroad in China, and is fluent in Mandarin Chinese. Alex also enjoys rock climbing and indulges in tabletop gaming.
Sarah Boynton is a recognized expert in biologics and Advanced Therapy Medicinal Products (ATMP) commercial manufacturing, specializing in Human and Organizational Performance (HOP). With over 15 years of experience, Sarah has held key roles in operations, deviation management, and training management, and has also served as a consultant for large organizations in these areas.
In addition to her professional career, Sarah is dedicated to mentorship and leadership development, currently serving as the Women in Bio Capital Region MAPS Chair, where she supports programs focused on women’s empowerment.
Having contributed significantly to industry leaders such as Lonza, Qiagen, Roosterbio, Emergent Biosolutions, and CBMG, Alex brings a blend of technical acumen with hands-on expertise. As a career QC scientist and growing compliance expert, she has consistently demonstrated a commitment to operational excellence and continuous improvement.
Alex holds an undergraduate degree in Biochemical Engineering from UMBC and a graduate degree in Biomedical Engineering from Clemson University. Beyond the laboratory, she brings a global perspective, having lived abroad in China, and is fluent in Mandarin Chinese. Alex also enjoys rock climbing and indulges in tabletop gaming.
Sarah Boynton is a recognized expert in biologics and Advanced Therapy Medicinal Products (ATMP) commercial manufacturing, specializing in Human and Organizational Performance (HOP). With over 15 years of experience, Sarah has held key roles in operations, deviation management, and training management, and has also served as a consultant for large organizations in these areas.
In addition to her professional career, Sarah is dedicated to mentorship and leadership development, currently serving as the Women in Bio Capital Region MAPS Chair, where she supports programs focused on women’s empowerment.