Sandra A. Lowery

Sandra A. Lowery
President

Email: slowery@qsconsult.com

Sandy Lowery has been a consultant to the pharmaceutical and biotech industry since 1998. 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 programs, and process/systems/equipment validation. Ms. Lowery 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, she 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. In 2011, she was a contributing author to the revision of PDA Technical Report 22: Process Simulation for Aseptically Filled Products. She is also a contributing author to the PDA-Davis Horwood publications entitled Microbiology in Pharmaceutical Manufacturing (Editions 1 and 2), with chapters on Designing A Contamination Control Program and Validating A Contamination Control Program.


Maureen J. Mueller
Consultant
E-mail: mreagan@qsconsult.com

Maureen Mueller joined QSC in 1999 as a consultant to the pharmaceutical and biotech industry. Prior to that, she spent 18 years in 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, and validation. 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 in August 2001 and the revision of PDA Technical Report 22: Process Simulation for Aseptically Filled Products in 2011. She is also a contributing author to the Davis Horwood publication entitled Microbiology in Pharmaceutical Manufacturing - Edition 2, with a chapter on Designing and Validating A Contamination Control Program.

Maureen J. Mueller

Amy A. Clark

Amy A. Clark
Consultant
E-mail:
  aclark@qsconsult.com

Amy Clark joined QSC in 2002 as a consultant to the pharmaceutical and biotech industry. Prior to that, she spent 21 years in pharmaceutical, biological and medical device manufacturing specializing in the managament of manufacturing operations, facilities and validation.  Her expertise includes aseptic manufacturing, biologics and medical device processes. She has extensive experience with isolator technology, blow fill seal and complex aseptic processing. She has worked extensively with qualification of equipment, sterilization, decontamination, cleaning and process validation. She works with engineering and critical utility systems, calibration and packaging operations. She recieved her B.S. in Biology from Illinois State University. She is a member of the Parenteral Drug Association (PDA) and International Society of Pharmaceutical Engineers (ISPE). While in ISPE she led the Government Relation Committee, which worked extensively with FDA to build a positive relationship with ISPE and industry. She is a past member of the Board of Directors for ISPE and made frequent presentations at ISPE conferences to industry on aseptic manufacturing and validation practicies.