Speaker Biographies

2008 PMF Fall Forum

Recent Advances in Environmental Monitoring

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Carol Bartnett
Steris Corporation

Carol Bartnett is a senior scientist in the R&D Microbiology Laboratory at STERIS Corporation, where her current focus is microbiological testing related to research and development of antimicrobials for the Life Sciences and Healthcare markets.    Prior to joining STERIS, she worked as a microbiologist at GlaxoSmithKline and Mallinckrodt Diagnostics.  She has over 20 years of experience in the field of pharmaceutical microbiology including quality assurance, quality control, plant troubleshooting, environmental monitoring and disinfection of cleanrooms, USP microbiological and sterility testing, preservative effectiveness testing, purified water systems, Good Manufacturing Practices, and FDA regulations.    Ms. Bartnett has a B.S. in Microbiology and is a NRM Specialist Microbiologist in Consumer and Industrial Microbiology. 

Michael Cable
Argo Therapeutics

Mike Cable has been the Validation Manager at Argos Therapeutics in Durham, NC for over five years.  His responsibilities include equipment and facility qualification activities for GMP manufacturing of autologous immunotherapeutic cancer and HIV products currently in Phase 2 clinical trials.  Mike started his career as an Electronics Technician in the Navy Nuclear Power Program, serving as Reactor Operator aboard the USS Los Angeles submarine.  After leaving the Navy, Mike spent 11 years at Performance Solutions performing technical services for the pharmaceutical industry, highlighted by an assignment to Eli Lilly Corporate Process Automation managing Instrument Qualification projects for new facility startups.  His practical experience in instrumentation and controls led him to his current career path in Validation, which has been his main focus for the past 12 years. 

Anne Marie Dixon
Managing Partner, Cleanroom Management Associates

Anne Marie Dixon is the Managing Partner of Cleanroom Management Associates, a consulting firm that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.  

She has been actively engaged in the field of contamination control for over two decades with extensive experience in the areas of training, technical writing, strategic consulting, facility start-up, construction protocols and process optimization. She has trained over 150,000 cleanroom technicians and managers.      

A University of Illinois graduate, she has published over ninety technical articles and three books including How to write a training manual published in 1997 by Micron Video International.   Anne Marie was the first woman to be elected President of the IEST and was appointed to the position of FELLOW in 1998. She is the first recipient of the James P. Agalloco Award for Excellence in Training and is an active member of the PDA, IEST, ISPE, ASQ, SSA and AMA. She is also an ISO 9000 trained auditor.  In addition, Anne Marie is the head of the U.S. Technical Advisory Group - TC 209 and represents the USA on the ISO Technical Committee 209 on Cleanrooms and Associated Controlled Environments.  

Richard Forsyth
Associate Director GMP Quality – Commercialization & Early Development, Merck & Co, Inc

Richard Forsyth is an Associate Director with GMP quality at Merck & Co., Inc.  He is responsible for internal and external facility audits as well as document audits for regulatory submissions.  He has worked in Quality for three years and prior to that worked as an Analytical Chemist in Pharmaceutical R&D for 23 years.  He has been involved with Cleaning Validation for over 15 years.  Mr. Forsyth has a broad range of GMP/GLP analytical experience including methods development and validation as well as formulation development and project management.  He is an adjunct Professor in the QA/RA graduate program at Temple University.  Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, Pennsylvania, USA.

Aaron Hubbell
Eli Lilly

Aaron Hubbell has nearly a decade of experience with environmental monitoring in the pharmaceutical industry in aseptic, bulk API, and biotechnology production facilities. He has spent the last four years designing and managing environmental monitoring programs for Eli Lilly and Co.'s clinical trial production facilities, managing critical utility qualification projects (high purity waters and compressed gases), authoring corporate policies regarding environmental monitoring and bioburden control, and consulting for various bioburden control projects. Aaron holds a Bachelor of Science in Biology from Marian College and is a certified Six Sigma Green Belt.  

Scott Sutton, Ph.D.

Senior Director of Microbiology Services, Vectech

Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Vectech Pharmaceutical Consultants, Inc.  Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest.  He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000.   He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals.  Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups.  This service also supports two Email lists, the first devoted to pharmaceutical microbiology (http://www.microbiol.org/pmflist.htm) and the second devoted to pharmaceutical stability (http://www.microbiol.org/psdglist.htm).

Kasthruri Venkateswaran
Jet Propulsion Laboratory

Dr. Venkateswaran’s 30 years of research encompass marine, food and environmental microbiology. He has applied his research in molecular microbial analysis to better understand the ecological aspects of microbes, while conducting field studies in several extreme environments such as deep sea (2,500 m), spacecraft (Mars Odyssey, Genesis, MER, Mars Express) assembly facility clean rooms (various NASA and ESA facilities) as well as the space environment in Earth orbit (International Space Station). Of particular interest are microbe-environment interactions with emphasis on the environmental limits in which organisms can live. The results are used to model microbe-environment interactions with respect to microbial detection, and the technologies to rapidly monitor them without cultivation. The bioinformatics databases generated by Dr. Venkateswaran are extremely useful in the development of biosensors. Further, these models or information in database are extrapolated to what is known about the spacecraft surfaces and enclosed habitats in an attempt to determine forward contamination as well as develop countermeasures (develop cleaning and sterilization technologies) to control the problematic microbial species. Specifically, his research into the analysis of clean room environment using state-of-the art molecular analysis coupled with nucleic acid and protein-based microarray, will allow accurate interpretation of data and implementation of planetary protection policies of present missions, helping to set standards for future life-detection missions.