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.
George M. Levinson
Mr. Levinson is one of the founding principals of Compliance Software Solutions Corp. located in Buffalo Grove, Illinois. Since starting the company in early 1999, he has directed and managed all business operations, and sales and marketing initiatives. CSSC develops and provides software programs, system support documentation, and associated technical resources to the pharmaceutical, biotechnology, and medical device industries to help ensure compliance with regulatory and industry guidelines in the manufacture of their products. The company’s lead product, the Microbiology Information Management System (MIMS©) is an automated program that provides a documented and validated means of collecting, managing and reporting environmental and water data. The company’s patent (US 6,904,370) System, Method, And Computer-Readable Medium For Collection Of Environmental Data And Generation Of User Reports For Compliance With FDA Requirements was issued and published by the U.S. Patent and Trademark Office on June 7, 2005.
Mr. Levinson has over 25 years of domestic and international sales and marketing experience in the regulated health care industry. Throughout his career he has held senior level management positions with companies that include American Hospital Supply Corp., Baxter Healthcare, and G.D. Searle. He also spent several years in venture capital developing healthcare data management and sterility assurance companies. Prior to starting CSSC he managed a successful consulting practice focused on market research and strategic planning for the pharmaceutical and biotechnology markets.
Mr. Levinson holds a B.S. degree in Biology with specialization in Biochemistry from Binghamton University in Binghamton, New York. He received his MBA from Keller Graduate School in Chicago, Illinois. He is a contributing author to the Davis Healthcare publication entitled Environmental Monitoring A Comprehensive Handbook – Volume 2, with a chapter on "Implementation And Automation Of The MIMS System".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."