Web Code: MicroB3-11
Member/Nonmember Price: $75
Contamination control is paramount for ensuring product and patient safety and is a frequently encountered challenge for the Pharmaceutical Microbiologist. Upstream microbial controls, operator focus on aseptic technique, and early detection of contamination provide process control for drug manufacturing and ensure compliance to industry regulations and quality standards. In this seminar, speakers will present case studies of and best practices for processes employed to detect and control contamination in drug products.
The seminar will discuss the following topics on contamination control: Contamination pathways in primarily non-sterile pharmaceutical manufacturing settings from the perspective of a contract environmental monitoring laboratory, lessons learned from investigations into contamination of pharmaceutical production equipment due to process equipment design and ineffective cleaning practices, and the genesis of biofilms in compendial water and other fluid systems.
Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation Level of Expertise: Executives, Management, Scientists / Technicians
Abby Roth, Microbiologist II, Microbiological Environments
Abby Roth has been with Microbiological Environments since 2004, where she is responsible for the analysis of environmental monitoring samples and client consultation, as well as microbiological examination of non sterile product testing. She holds a B.S. degree in Biology from York College of Pennsylvania, is a member of ASQ and is a Certified Quality Improvement Associate.
Andrew Dick, Senior Manager QA Microbiology, Johnson & Johnson Consumer Group of Companies
Andrew Dick has been with Johnson & Johnson Consumer for six years, responsible for the development of standards/policies to prevent microbial contamination in both non-sterile and aseptic processing, troubleshooting and leading contamination events, conducting training for manufacturing facilities on microbial contamination prevention and auditing of Microbiology laboratories for cGMP compliance
Andrew Dick has food, industrial, drug, personal care products and clinical Microbiology experience, and holds a M.S. in Microbiology.
Marc W. Mittelman, PhD, Senior Managing Scientist, Exponent ® and Visiting Scientist, Harvard University School of Engineering and Sciences
Marc is a Senior Managing Scientist in Exponent’s Health Sciences Center for Occupational and Environmental Health. He is also a visiting scientist at Harvard University, School of Engineering and Applied Science. Marc has over 25 years experience in academia, industry, and consulting. The majority of his research and consulting work has been in the area of microbiological contamination detection and mitigation for pharmaceutical/biotechnology, clinical, and industrial applications. Marc has developed test systems and analytical methods for monitoring biofilm development on engineered materials, and has conducted a number of studies on the contamination of critical components from the International Space Station for NASA. He provides consulting services in the fields of biological fouling (biofouling), microbially influenced corrosion (MIC), purified water system contamination control, medical device-related infections, and antimicrobial development. Marc was previously an Associate Professor in the Faculties of Medicine and Dentistry, and director of the Centre for Infection and Biomaterials Research (CIBR) at the University of Toronto. He has also worked as a microbiologist in the pharmaceutical industry, and directed a microbiology consulting practice. Marc is the author of over 80 scientific papers and books.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093