Send us your interest if this course is currently not offered or the current schedule does not accomodate your schedule. It is often necessary to understand interest a semester in advance for planning and scheduling. Companies and organizations can often request a course if the group is large enough. This doesn't mean that we can make accommodations in every case. However, we will utilize and maximize our available resources as best as we can. Thanks for letting us know your interests and we will respond as soon as we can.
This course provides practical applications in monitoring to control a process. Topics include equipment and process validation, Installation Qualification (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ), monitoring in-process operations, and reporting of deviations or excursions from process parameters. Additionally, the importance of media fills to validated sterile fill operations will be discussed. Upon completion, students should be able to demonstrate the importance of understanding processes and the steps to monitoring the variables to ensure reproducibility. Topics include validation, monitoring in-process operations, pressure measurement devices and calculations, temperature calculations, density measurements and calculations, common manufacturing equipment, and recording data.