Environmental monitoring (EM) of manufacturing is a critical aspect of microbial quality control in pharmaceuticals. For large pharmaceutical companies with campus environments, performing EM testing can be a time-consuming process. Microbiologists must travel to the manufacturing area, gown in, take samples, then return to the lab to commence incubation enumeration and reporting of test results.
New options are available to simplify this process and make it more efficient. Listen to Amy McDaniel, Director of Technical Operations, as she discusses moving environmental monitoring testing closer to the manufacturing floor.
About Amy McDaniel:
Amy McDaniel is a Director of Technical Operations at the Sanford, NC facility for Pfizer, where she oversees a department responsible for implementing new technologies for the manufacture of intermediates for a conjugated bacterial vaccine.
Her Department is also responsible for cleaning validation, process validation, process monitoring and technology transfer for new clinical vaccines form R&D to Production Operations.
Historically, Amy has led two manufacturing departments at the Sanford facility, as well as the QC Microbiology department.
Prior to joining the Sanford team in 2009, Amy led the QC Microbial Science & Technology function and then the QC Microbiology laboratory for 9 years at the Pfizer Andover Facility in Massachusetts.
She holds Masters and Ph.D. degrees in Microbiology & Molecular Genetics.
She is the author of numerous presentations and book chapters on the topic of rapid and alternative methods in microbiology.
This event was sponsored by Rapid Micro Biosystems and held on October 2, 2014.