PDA & MODA Launch New Environmental Monitoring Handbook
The Parenteral Drug Association (PDA) and Davis Healthcare International Publishing (DHI) have published volume three of “Environmental Monitoring: A Comprehensive Handbook”. The book–edited by well-known industry expert, Jeanne Moldenhauer, Ph.D.–addresses current scientific, regulatory and technology environmental monitoring (EM) concerns for both aseptic processing and isolation technology.
Contributing mobile computing experts Robert Toal and Michael Goetter from MODA Technology Partners authored the chapter, “Best Practices in Environmental Monitoring Automation”. The chapter describes key concepts and requirements for introducing automation into the clean room and laboratory environments to enable a more effective quality control (QC) program. Additionally, the chapter includes Pharmaceutical case study contributions from Lonza Walkersville, Inc. and ImClone Systems, Inc. discussing experiences with the introduction of these concepts via deployment of the MODA-EM™ product at their manufacturing facilities.
Richard V. Levy, Ph.D., Sr. Vice President of Scientific and Regulatory Affairs, at the Parenteral Drug Association explains, “PDA is very pleased that the EM Handbook Volume 3 made our best seller list. The Handbook is a valuable resource for the industry, and I want to thank MODA and their co-authors for their contributions.”
The book can be purchased at the PDA Bookstore: https://store.pda.org/bookstore/ProductDetails.aspx?productabbreviation=17285
The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at http://www.pda.org.
More science. Less paper. MODA Technology Partners (http://www.modatp.com) provides a mobile data acquisition platform that enables quality assurance and quality control organizations in the Life Sciences industry to automate their regulated manufacturing processes, including environmental monitoring (EM), utility testing, and product testing. MODA’s flagship software, MODA-EM™, is a paperless QC Micro solution that leverages mobile computing technology and advanced visualization tools for increased operational efficiency, improved quality, and reduced costs. MODA enables companies to advance their Green Initiatives by reducing and eventually eliminating the need for paper-based, labor-intensive EM programs. MODA is headquartered in Wayne, Pennsylvania with authorized resellers and technology integration partners throughout North America and Europe.
Source : PDA