Good Laboratory Practices for Food and Dietary Supplement Testing
A course designed and presented by EAS Consulting Group and Silliker-Merieux NutriSciences
July 21-22, 2015
This two-day intensive program will discuss Good Laboratory Practice and Current Good Manufacturing Practice requirements for food and dietary supplement laboratories. The course will cover analyst training and qualification; the lab physical facility and environment; internal and external audits; quality agreements with lab contractors; instrument calibration and maintenance programs; computer systems; samples and sampling schemes; microbiology practices and procedures; lab SOPs; change control; FSMA update; analytical documentation; reference standards, reagents, and solutions; test method development, validation, and transfer; expiration dating and stability testing programs; lab out-of-specification (OOS) investigations; lab safety requirements and programs; lab accreditation ISO 17025; managing FDA inspections. Participants will gain an understanding of the importance of good laboratory practice for obtaining and reporting credible analytical results, as well as the 21 CFR Part 111 CGMPs for Dietary Supplements as they pertain to laboratory operations. FDA issues of concern will be highlighted throughout the program with emphasis placed on recent FDA regulatory or administrative actions. Case studies will be presented covering key lab processes and procedures. Who Should Attend:
This program would benefit individuals involved in Regulatory Affairs, Quality Control/Quality Assurance, Manufacturing, Research & Development, Validation/Qualification, as well as laboratory analysts, supervisors and managers. It will be of particular interest to those charged with implementing, validating and maintaining laboratory compliance programs. Course Dates:
July 21-July 22, 2015 Course Location:
Hyatt Regency O'Hare Registration:
9300 West Bryn Mawr Ave
Rosemont, IL 60018
William (Bill) Ment
EAS Consulting Group - Senior Advisor for Drug/Dietary Supplement Audit Services David Evanson
With 34 years of FDA laboratory experience, Mr. Ment advises EAS clients on laboratory and quality assurance issues. His experience is broad and far-reaching. In his last position with FDA, Mr. Ment was the Laboratory Director in Baltimore, MD, with responsibility for a full range of FDA field lab sample analyses and research studies for imported and domestic products, including pharmaceuticals, in vitro diagnostic devices, microbiological, environmental contaminants, and extraneous materials/decomposition in foods. Since 1970, he has been responsible for developing, implementing and assessing laboratory quality assurance systems and procedures, and training and evaluating personnel in their use. For the past 16 years he has served as a consultant to the pharmaceutical and dietary supplement industries in evaluating CGMP compliance of production, quality unit, and laboratory operations; assisting companies in identifying and implementing corrective and preventive actions for CGMP deficiencies; and helping companies respond to FDA-483 observations and warning letters.
Technical Consultant, Silliker, Inc.
Mr. Evanson is a food safety authority with an extensive background in laboratory management, quality management, ISO accreditation, laboratory design, consulting and training. He began his career in 1979 as a Senior Technician for Beatrice Foods Company and joined Chicago Heights-based Silliker Laboratories in 1982. He held various leadership positions at the company, including Laboratory Director and General Manager, between 1993 and 1996. From 1996 to 2007, Mr. Evanson served as Vice President of Analytical Services for Silliker, Inc. and later held the position of Corporate Vice President of Quality. He has written and lectured extensively on the microbiological safety of food products and is a member of professional groups, including IAFP, AOAC and IFT. Mr. Evanson is a Technical Consultant for Silliker, Inc. About EAS:
EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. Our prime focus is to assist domestic and foreign food, dietary supplement, pharmaceutical, medical device, tobacco and cosmetic firms comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience. EAS is headquartered in Alexandria, VA with consultants and auditors located strategically throughout the world. About Silliker-Merieux NutriSciences:
As part of Institut Merieux, Merieux NutriSciences is dedicated to protecting consumers’ health throughout the world, by delivering a wide range of testing and consulting services to the food & nutrition, agrochemicals, pharma and cosmetics industries.
5th Annual and Drug Law CLE
All Matters FDA: Crimes, Misdemeanors, and More
Wednesday, March 25; 1:00 – 3:00 pm
Hosted by: Widener University School of Food and Drug Administration
For more information and to register please visit: law.widener.edu/fdacle