Vaccines R&D & Vaccination

Jeanne Moldenhauer, Vice-President of Excellent Pharma Consulting has more than 30 years’ experience in the pharmaceutical industry. She chaired the Environmental Monitoring/Microbiology Interest Group of PDA for more than 15 years, served on the Scientific Advisory Board of PDA for 20 years, founded the Rapid Microbiology User’s Group™, and is a Member of ASQ and RAPS. She is the author of many books and numerous publications (book chapters and magazine articles)

In this every changing world of regulatory expectations, developing a regulatory strategy for environmental control can be challenging. It will describe the various components of the program, how the components interrelated, and what the requirements are for each component.  Additionally, it will discuss the various regulatory requirements for this type of monitoring.  Lessons learned and typical regulatory observations for these types of systems will also be discussed.  Lastly, discussion will be conducted on the various methods available for automation of these systems.  This discussion includes the type of reports and trending expected for the program.