November General Meeting  

"Risk Analysis and Management"

Presented by

Mr. Allen Burgenson,
Manager, Regulatory Affairs, Lonza Walkersville, Inc.

Thursday, November 15, 2007

At the
The Golden Bull Restaurant
In
Gaithersburg, MD

The cost is $10.00 for ASQ members and students or $20.00 for non-members.

Please register using the link above or by contacting Vijaya Thadikonda at (713) 292-4384 or [email protected]    Please note:  Meal preferences cannot be guaranteed if one is not registered by Tuesday, November 13, 6:00pm.

Important Notice: ASQ Section 509 is responsible for the meals for all �No shows� at The Golden Bull Restaurant.  Please help us control our losses by notifying our Program Chair Vijaya Thadikonda at (713) 292-4384 or  to cancel your dinner prior to the event.  Thank you for your cooperation!

Program Summary:

Understanding all aspects of Quality Risk management, which include analysis, control, mitigation evaluation and communication of risk.  Risk is something that we all encounter and manage every day in our personal and working lives.  This presentation describes various sources of risks and several methods to evaluate those risks.  The presentation will also propose various strategies to mitigate those risks.

Speaker Biography:  Allen L. Burgenson

Allen L. Burgenson is the Manager of Regulatory Affairs for Lonza Walkersville, Inc., a supplier of test kits, reagents, raw materials, and components for research and FDA-regulated companies.  The company also provides contract manufacturing facilities and services for FDA-regulated companies.  Mr. Burgenson has over 24 years of experience in FDA-regulated industries, including Food, Drugs, Biologics, and Medical Devices.  This experience includes the areas of Quality Control, Quality Assurance, Validation, and Regulatory Affairs.  He is currently the President of the Capital Area Chapter of the Parenteral Drug Association (PDA), and has served on the Program Committee for the PDA/FDA Joint International Regulatory Conference for three years, including the Chair in 2004.  Mr. Burgenson holds a MS in Biotechnology Management from the University of Maryland, and a BA in Microbiology from Rutgers University.

See November 2007 General Meeting Announcement for more information and directions to the Golden Bull Restaurant.