SCIENTIFIC SYMPOSIUM
Validation and Verification of Laboratory Methods
Industry Needs and Regulatory Expectations
Tuesday, August 3, 2010 Anaheim, CA – Hilton Anaheim
Anaheim, CA – Hilton Anaheim
Program Moderator: Michael Brodsky
6:00PM - Registration and Hors d'oeuvres
7:00PM – Program
Food and Beverage to follow
The first 100 registrants will receive a complimentary copy of Introduction to Microbiological Indicators in the Food Industry, the first monograph in a series of publications focused on the theme of microbiological indicators.
Symposium Abstract
Regulatory agencies are increasingly requiring commercial and industry laboratories to use validated microbiological methods and to verify that they are using these methods according to the validated procedure. Additionally, laboratories must demonstrate that the matrix being tested was included in the original validation or that additional verifications studies have been conducted. Increasingly, companies are accrediting their laboratories to meet the demands of their customers and regulators. Finally the laboratory must demonstrate proficiency in their microbiological testing procedures. A distinguished panel of experts will provide insights into the latest developments in validation and verification of laboratory methods and participate in an open discussion with symposium attendees.
Program Agenda
Alexandre Mérieux
Welcome and Introduction
Michael Brodsky [Bio], BRODSKY CONSULTANTS
What are Validated and Verified Methods and Why do We Need Them?
Carl J. Sciacchitano [Bio], DIRECTOR, DIVISION OF FIELD SCIENCE, U.S. FDA, OFFICE OF REGULATORY AFFAIRS
FDA Expectations for Industry Food Laboratory Methods Validations
Victor Cook [Bio], MICROBIOLOGY DIVISION, OFFICE OF PUBLIC HEALTH, USDA/FSIS
FSIS Expectations for Industry Food Laboratory Methods Validations
Brad Stawick [Bio], INDEPENDENT AUDITOR, STAWICK LABORATORY MANAGEMENT
Experiences of an Independent Auditor of Food Laboratories
Matilda Freund [Bio], SR. DIRECTOR - WW FOOD SAFETY, KRAFT FOODS
Challenges of Meeting Regulatory Requirements in Different Countries: Experiences of a Global Food Company
L. Victor Cook, Jr. is the Chief of the Microbiological Issues Branch within the USDA Food Safety Inspection Service (FSIS) Office of Public Health Science (OPHS) Microbiology Division in Washington, D.C. FSIS is the federal public health agency that provides regulatory oversight for the safety of meat, poultry and certain egg products. Victor has been involved in microbiological food safety testing issues since he began his career with FSIS at Eastern Field Service Laboratory more than 30 years ago. Victor and his staff play a leadership role for a variety of microbiological issues within FSIS including the technical assessment of testing programs and methods used by U.S. industry and countries that export meat, poultry and egg products to the U.S. Victor has an M.S. in Medical Microbiology from The University of Georgia.Michael Brodsky was hired by the Laboratory Services Branch of the Ontario Ministry of Health in 1971, after graduating from the University of Toronto, School of Hygiene, with a Diploma in Bacteriology and his Masters Degree in Microbiology. In 1982, Michael accepted and held the position of Chief, Environmental Microbiology for the Ontario Ministry of Health until he changed career paths in 1999. He currently operates as an independent microbiological consultant in food and water safety and laboratory accreditation. Michael is a Past-president of the Ontario Food Protection Association (twice), Past-president of the International Association of Milk, Food and Environmental Sanitarians (IAMFES) now known as the International Association for Food Protection (IAFP) and Past-president of AOAC International Inc. Mr. Stawick is a laboratory and food safety consultant. He has over 15 years of experience in performing quality assurance, safety, process improvement, and microbiological testing, including traditional cultural methods, ELISA, PCR, and serological techniques. Mr. Stawick has worked for two major testing laboratories in many capacities including Laboratory Director, Corporate Director of Quality and Safety, and Chief Microbiologist. He has experience with GMP, GLP, AOAC, FDA requirements, laboratory accreditation, automation, and process improvements. Mr. Stawick holds a Masters of Science degree in Food Science and a Bachelor of Science degree in Biology, both from the University of Illinois at Urbana. Matilda is Sr. Director of Food Safety and Microbiology for Kraft Foods worldwide. Her responsibilities include the development and implementation of food safety strategies and related policies, systems, programs and services. This includes toxicology, thermal processing, microbiology, HACCP, and the certification and maintenance of microbiological methods and testing facilities. In addition, her team works closely with product development to ensure appropriate design and stability from product, process and distribution perspectives.
Matilda joined Kraft in 1990 as a Microbiologist in Tarrytown, NY. She has worked in the areas of R&D, Sanitation and Quality as well as production management. At the end of 2002, she joined the International group and was based in Munich Germany for 5 years. She returned to the US in 2007.
Matilda holds a PhD and Master of Science in Food Science and Human Nutrition and a Bachelor's degree in Microbiology and Cell Science from the University of Florida.
Carl received his B.S. degree from the University of South Carolina in 1985 and his master degree from New York Medical College in 1992. From 1990 – 1998 he was a senior microbiologist at the Northeast Regional Laboratory primarily involved in the development of molecular biological methods for regulatory analyses. From 1998 – 2004 he served as a senior microbiologist for the DFS leading to his promotion to Director. His tenure with the FDA is highlighted by two national programs to advance the protection of public health; the development of the Electronic Laboratory Exchange Network (eLEXNET) and a key founder of the Food Emergency Response Network (FERN). He is currently heading the FDA's effort to revitalize laboratory capacities and capabilities including preventative technologies, rapid screening platforms, automated laboratory management and optimization of laboratory operations.
