Web Code: MicroP5-11
Member/Nonmember Price: $75
While harmonized compendia have proposed a Microbial limit for non-sterile products and specified microorganisms to be looked at, they couldn’t propose an exhaustive positive list of microorganisms to be free of. Additionally, the concept of “free of” doesn’t exist in microbiology any more than it would exist in chemistry; it is only a question of how precise the Ruler you use is or how big is your sampling size. Therefore, it is reasonable to expect frequency of a low level microorganisms recovery during process steps or finish good control. When a microorganism is recovered, it is routine to perform identification and an assessment. Unfortunately, in several situations, the assessment is fairly limited and the “name” of the microorganisms drives the decision to an extreme. This seminar will review the way a microorganism shall be assessed to determine when it must be considered as objectionable or not. The review will focus on 2 distinct aspects: The impact of the microorganisms on product performance and the impact of the microorganisms on patient safety.
Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation Level of Expertise: Executives, Management, Scientists / Technicians
Anthony, Cundell, PhD, Director, Analytical Sciences - Microbiology, Merck Sharp & Dohme Corporation
Dr Tony Cundell works for Merck Research Laboratories in Summit, New Jersey as the Director, Analytical Sciences - Microbiology in early phase drug development. He directs a staff of 16 microbiologists working in laboratories in Summit, New Jersey and West Point, Pennsylvania. Among his many accomplishments as a pharmaceutical microbiologist, Tony Cundell was Chair of the PDA Task Force responsible for the publication of the groundbreaking 2000 Technical Report #33 “The Evaluation, Validation, and Implementation of New Microbiological Testing Methods”. He is a member of the 2010-2015 U.S. Pharmacopeia Microbiology Committee of Experts responsible for standard setting for the pharmaceutical industry. In addition, he has published extensively in the areas of rapid microbial methods, water activity determination, sterilization processes, microbial identification and risk assessment.
In June, 2009, he co-edited with Anthony Fontana a book entitled “Water Activity Applications in the Pharmaceutical Industry” and contributed two chapters to the book.
Dr. Cundell has a Ph.D. in Microbiology from the Lincoln University, New Zealand as well as both a M.Sc.(Hons) degree in Biochemistry, and a B.Sc. degree in Biochemistry and Chemistry, Victoria University of Wellington, New Zealand. He lives with his wife Roz who is an advertising copy writer in Scarsdale, New York.
Judith Noble-Wang, PhD, Lead Research Microbiologist, Centers for Disease Control and Prevention
Dr. Noble-Wang has been with the Centers for Disease Control and Preventions as a microbiologist since 2004 in the Clinical and Environmental Microbiology Laboratory Branch, Division of Healthcare Quality Promotion. She became a lead research microbiologist in 2008. Her interest includes the role of the environment in transmission of healthcare associated infections caused by methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, Clostridium difficile, multi-drug resistant gram negatives such as Acinetobacter baumannii. She manages biofilm, preparedness and environmental infection control research and is also responsible for laboratory support for healthcare outbreaks. Previously Dr. Noble-Wang, was a quality control microbiology specialist and technical services scientist at Wyeth Pharmaceuticals (now Pfizer, Inc.). She holds a PhD from Georgia State University with emphasis in Applied and Environmental Microbiology.
Amy McDaniel, PhD, Director, QC Microbiology, Pfizer, Inc.
Amy McDaniel is the Director of the QC Microbiology department at Pfizer in Sanford, N.C., where she oversees a team responsible for the routine testing and support for microbiological assays for the commercial vaccine manufacturing operation. Prior to coming to Sanford in 2009, Amy led the QC Microbial Science & Technology function and then the QC Microbiology laboratory for 9 years at the Pfizer Andover facility in Massachusetts, which manufactured recombinant proteins in mammalian cell culture as well as polysaccharide vaccine components. She led the implementation of a rapid microbiological method for in-process bioburden testing of cleaning validation rinse water and swab samples, and is currently on the team for implementing rapid microbiology across Pfizer. She holds Masters and Ph.D. degrees in Microbiology & Molecular Genetics from Rutgers University. Amy has been working in microbiology for 15 years, and has given numerous presentations and papers on the subject of rapid microbiology.
James J. Leyden, M.D., Emeritus Professor of Dermatology, Department of Dermatology, University of Pennsylvania School of Medicine
Dr. Leyden received his Medical Degree from the University of Pennsylvania, where he has been involved in clinical research and care of patients for more than 40 years, becoming an Emeritus Professor of Dermatology in 2002. Dr. Leyden has served on numerous editorial boards, was a Director of the American Academy of Dermatology and Chairman of the Board of the Dermatology Foundation for a number of years. He is presently serving on the Board of the Dermatology Foundation.His research interests encompass a wide range of clinical problems including bacterial and fungal infections, acne, aging and photoaging, pre-clinical safety testing and developing methodologies for in-vivo evaluation of anti-microbial effects. More basic interests have included mechanisms of inflammation in acne, bacterial taxonomy and bacterial production of body odors. These studies are found in more than 300 publications, numerous chapters and several books.
Jason E. Brown
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