Cleanrooms are a crucial part of pharma manufacturing processes, scientific research and quality control. Constructing and qualifying a new cleanroom requires a huge investment of money, time, and resources. Given the cleanroom’s role in product quality, there are extensive regulatory requirements surrounding cleanroom design and validation and meeting these guidelines requires careful consideration. This webinar will walk through key elements that should be considered when setting up a pharma cleanroom.
Marie France Quillen is the Senior Technology and Market Development Manager for Charles River. With nearly two decades of experience in the life science industry, Marie has a proven track record of driving results within pharma operations. Marie’s functional expertise includes quality control, laboratory testing, engineering, manufacturing and quality operations. Marie has extensive experience in aseptic production and successfully automating endotoxin testing programs within a GMP environment. She has worked with specialty APIs, vaccine products and insulin products and is skilled in compendial microbiological testing methods, analytical method transfer, sterility testing, growth promotion, method/development validation and equipment validation. Marie received her Bachelor of Science in Biological Sciences, with minors in Chemistry and Microbiology, from the Metropolitan State University of Denver.