Meet the Team...
Our faculty is composed of industry experts from around the world. We provide expert training by explaining the concepts, demonstrating the techniques in actual laboratory settings and verifying the understanding of those concepts. Some team members include:
John Lindsay - Executive Director and Founder
(click here to view a message from the founder)
John has been a consultant to the pharmaceutical industry for the past ten (10) years. Prior to that, he had 27 years experience in industry in roles of Quality Control (Labs), Quality Assurance and Manufacturing, with companies including Genentech, Burroughs Welcome and Marion Merrell Dow. He holds a Master’s Degree in Microbiology from Kansas University Medical School, is a Registered Specialist Microbiologist by the American College of Microbiologists, and is the Former Chair of the National Registry of Microbiologists (six years).
For the past eight (8) years, he coordinated and led the PDA’s two-week Aseptic Processing course at the PDA Training and Research Institute in Baltimore, Maryland. John was a member of the PQRI Committee to provide input to the FDA’s Guidance to Industry on Aseptic Processing published in September, 2004. In 2007, John founded the Aseptic Training Institute, LLC, a facility dedicated to providing hands-on training to members of the pharmaceutical and biotechnology industries. The Institute currently has two training facilities—one in Clayton, North Carolina, and the other in Lisbon, Portugal.
Sandy Lowery - Course Director
Sandy Lowery has been a consultant to the pharmaceutical industry for the past ten (10) years. Prior to that, she spent 23 years in injectable pharmaceutical manufacturing, specializing in the areas of aseptic processing, validation, quality assurance, regulatory affairs, and aseptic process development. Her expertise includes the design and validation of aseptic processes, aseptic training, environmental monitoring, disinfection practices, and process, systems and equipment validation. Sandy received her BA in Science and Technology and an MBA from Southern Illinois University. She is the past and founding president of the Pharmaceutical Technical Exchange Association (10 years), which is a joint committee composed of FDA and industry representatives from the Kansas City FDA district. In 2003, Sandy served as a consultant to the US-FDA Advisory Committee for presentation of the 2003 Concept Paper on Sterile Products Produced by Aseptic Processing: Current Good Manufacturing Practice. She is also a contributing author to the Davis Horwood publication entitled Microbiology in Pharmaceutical Manufacturing, with chapters on "Designing and Qualifying A Contamination Control Program."
Maureen (Reagan) Mueller - Course Director
Maureen has been a consultant to the pharmaceutical industry for the past ten (10) years. Prior to that, she spent 18 years in injectable pharmaceutical manufacturing, specializing in the areas of quality assurance, quality control, and regulatory affairs. Her expertise includes aseptic processing, environmental monitoring, microbiological testing, disinfection practices, document control systems, stability programs, annual product reviews, validation, and extensive interaction with the FDA. Maureen received her BS in Biology from the University of Missouri – St. Louis. She was a contributing author to PDA Technical Report 35: A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry. August 2001. She is also a contributing author to the Davis Horwood publication entitled Microbiology in Pharmaceutical Manufacturing – Edition 2, with a chapter on "Design and Qualification of A Contamination Control Program."