2011 Micro Conference - B1: Applications of Risk Assessment in the Microbiology Laboratory

Web Code: MicroB1-11
Member/Nonmember Price: $75

Seminar Summary

Risk assessments are becoming common in a number of areas associated with microbiology, including but not limited to environmental monitoring, aseptic processing, and assessing the impact of certain microbial species on the final product. In the area of environmental monitoring, risk assessments can justify the locations of samples and may be employed in the reduction of sampling locations.  In aseptic processing, risk assessment can be used to predict and subsequently correct areas of contamination risk for the process.  In assessing microbial identity in final products or processes, risk assessments can support an investigation and provide a rational approach for supporting product release or rejection.

This seminar will provide multiple examples of the use of risk assessments in microbiology, from EM, to aseptic processing, to microbial identifications.

Who Should Attend

Departments: Microbiology, Compliance, Engineering, Manufacturing, QA/QC, Development, Regulatory Affairs, Research and Development, Validation Level of Expertise: Executives, Management, Scientists / Technicians

Presenters Bio

Lawrence Lin, Ph.D., Principal Scientist, Baxter Healthcare, Corporation

Is a consulting statistician in industry.  Received Ph.D. in statistics from University of Iowa.  Employed at Baxter Healthcare Corporation as “Baxter Research Scientist: Statistics”.  Thirty years consulting experience in research and development (mostly animal toxicity and physiology studies), assay validation and methods comparisons, reliability of products, lab quality control (QC), virus assay and inactivation process, pharmacokinetics, marketing research, litigation, outcome research, product stability, and clinical trials.  Appointed as an Adjunct Professor in the Department of Mathematics, Statistics and Computer Science at the University of Illinois at Chicago since 1995.  Supervise student’s thesis.  Has graduated seven PhD students.  Sponsor and supervise students for summer internship and part time employment with Baxter.  Area of expertise includes robust statistics, general linear model (univariate or multivariate, continuous or categorical), discriminant analysis, transformation, statistical process control for rare events, and agreement assessment.

Sophia Nguyen, MS, MBA, Quality Lab Associate III, Baxter Healthcare, Corporation

Mrs. Nguyen has been with Baxter Healthcare, Corporation since 1999 in the Quality Control/Management laboratory. With a background in Biochemistry (UCLA graduate), she specialized in Recombinant protein process control and characterization, Final product formulation, Protein lyophilization, and Product stability. She was working in various areas such as Final product/ Product stability team, Immuno/ELISA team, and Validation and Method development team. Most recently graduated with her MS in Biotechnology and MBA, she also has moved to the Microbiology team in a technical support position. Her current tasks are to support resolving of compliant issues and Non-conforming investigations,  performing process validations,  developing process control programs for critical systems, environmental monitoring programs, and Final product/Raw Material/In-process bioburden testing. Areas of expertise includes Biotechnology, Recombinant proteins, Plasma derived proteins, Statistic Process Control, Validation and Method Development in the GMP production/laboratory.

Rhonda Ezell, QC Manager, Microbiology, Qualitest Pharmaceuticals

Rhonda Ezell has worked as a Microbiologist in the food and distilled beverage industries for over 15 years.  She is now the Microbiology Manager at Qualitest Pharmaceuticals in Huntsville, Alabama.  Her experience includes monitoring wastewater effluents from industrial plants, isolation and identification of microorganisms from environmental systems including cooling towers and in-process manufacturing systems.  She has developed Bioterrorism and HACCP Programs.  In her work in the pharmaceutical industry, Ms. Ezell has developed testing methods for the detection and determination of objectionable microorganisms in finished pharmaceutical products and raw materials.  She has also developed an extensive Risk Assessment Program to evaluate microorganisms found in pharmaceutical products and raw materials.  Ms. Ezell has developed programs for Bloodborne Pathogens in the food industry, Biological Threat Assessment Programs (in response to the events of 911), and programs to assess employee exposures to various pathogens encountered in the workplace.   Ms. Ezell holds a Bachelor of Science degree in Biological Sciences from the University of North Alabama and a Master of Science in Microbiology from the University of Alabama in Huntsville.  She is currently pursuing her PhD at Alabama Agricultural and Mechanical University. 

James M. Payne, Senior Manager, Quality Control, bioMerieux, Inc.

James Payne is the Senior Manager of the Quality Control department at bioMerieux, Inc. in Durham, N.C., where he leads a team responsible for the routine testing and support for biochemical and microbiological assays for the commercial manufacturing operations.  Mr. Payne holds a Bachelor of Science in General Science from Westfield State College.  James has been working in microbiology for over 12 years.

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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