Dietary Supplement Labeling Seminar
Dietary supplement manufacturers need to keep up to date on new and changing FDA labeling policies. Now that FDA has published the final GMP regulations it is anticipated that the regulation of dietary supplements will be given a higher priority. This will undoubtedly carry over to increased focus on labeling compliance. This seminar will provide all that is necessary to prepare labels that comply with FDA requirements. It will address the regulatory requirements for the mandatory labeling elements and will cover allowable dietary supplement claims. Attendees will participate in a workgroup exercise to facilitate their understanding of the regulations. The popular hardback labeling reference, Dietary Supplement Labeling Compliance Review will be provided to each attendee that registers for the seminar.
DATE AND LOCATION
December 2-3, 2009
EAS Consulting Group - Training Facility
1940 Duke Street, Suite 200
Alexandria, VA 22314
IN-HOUSE SEMINARS
EAS will conduct this seminar for individual firms upon request. Bringing the seminar in-house at your facilities can be a cost effective alternative to train your employees. It also allows the program to be tailored to your particular needs.
Contact Ed Steele for a price quote. 703-684-4408
INSTRUCTORS
James E. Hoadley, Ph.D. - Senior Consultant
Dr. Hoadley's 20-year FDA career, which began in 1987, includes work as a Research Scientist in the Center for Food Safety and Applied Nutrition (CFSAN), Division of Nutrition, and as a Toxicologist in performing food additive and GRAS petition safety reviews in the Office of Premarket Approval. With the passage of the Nutrition Labeling and Education Act (NLEA) he participated in the development of NLEA-implementing nutrition labeling and health claim regulations.
Over the past ten years, Dr. Hoadley's position had been as a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) with primary responsibilities in food label claim regulations. In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims. During this period Dr. Hoadley was involved in some of the most precedent-setting health claim regulatory problems as CFSAN adapted to the FDA Modernization Act provision for authorization of food label claims based on authoritative statements, the 1999 Pearson v. Shalala federal court decision that led to qualified health claims, and Pearson-related lawsuits.
Dr. Hoadley has been directly involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by CFSAN over the last decade. Dr. Hoadley has received the CFSAN Distinguished Career Service Award.
Dr. Hoadley earned his Ph.D. in Toxicology at the University of Cincinnati College of Medicine, and did postdoctoral research in Nutrition at the University of Florida. His Bachelor of Science degree is from Ohio State University with a Major in Agricultural Education.
Gisela Leon - Consultant
For Quality Management Systems in frozen food and ice cream production, Gisela Leon's 20 years of experience is outstanding. Her ability to streamline quality specifications is proven with her former position. She is also well-experienced in European food laws, multi-language labeling, and legal clearance of package labeling. Additionally, she is versed in U.S. regulatory labeling of food and dietary supplements.
After receiving her Master's degree in Food Technology Engineering, Ms. Leon received her DGQ Audit-Specialist Certification from the German Institute for Quality, and her Master's in Business Administration from George Mason University. For over 20 years she worked at Schšller Lebensmittel GmbH & Co KG, becoming a Director of Quality Management. While there she gained a wealth of experience in food law, assuring the marketability of 900 ice cream and bakery products that were sold in 25 countries in accordance with European food labeling laws and country regulations. She also streamlined multi-language labeling to the most efficient and compliant way. Her experience also included quality assurance, as she worked as a Technical Supervisor for 3 ice cream production plants in Germany and the company's 4Ð6 foreign plants. She supervised quality assurance for externally purchased frozen foods and baked products, and established the company's master test plans for raw material and ice cream products. She developed and established HACCP, evaluated raw materials, and ensured comparable methods in product evaluation. She gave presentations at various conferences about ice cream quality. She implemented and sustained the company's ISO 9001 quality management system both within Germany and in their foreign plants.
If your project calls for management experience in the frozen food industry or labeling, Ms. Leon is available for you. She speaks English, German, and French and can give your company first-hand knowledge on US/European food laws. She can assist your company in assuring your products meet U.S. and EU labeling requirements.
Ms. Leon has more than 4 years of consulting experience.
SEMINAR HANDOUTS
Each participant will receive:
- Dietary Supplement Labeling Compliance Review, 3rd edition.
- Participant's Manual
- EAS Type Size Guide
WHO SHOULD ATTEND?
- Individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of foods.
- Those responsible for preparing or reviewing dietary supplement labels. Consultants, auditors, attorneys and others interested in food labeling compliance.
AT THE BASIC SEMINAR YOU WILL
- learn FDA dietary supplement labeling requirements from regulatory experts.
- be able to ask questions of former FDA officials to get an understanding of how the Agency thinks.
- receive a valuable reference book and a Participant's Manual containing all slides and handout materials that will save you time and help assure your labels are in compliance.
- get an opportunity to apply learning in practical work sessions.
REGISTRATION INFORMATION
REGISTRATION FEE:
Dietary Supplement Labeling Seminar $1,200 (Includes (includes hardback copy of Dietary Labeling Compliance Review - a $184.99 value)
DISCOUNTS:
Federal/State Government Employees 50%
More than one participant/company 10%
METHOD OF PAYMENT:
Check or credit card payments are accepted.
MINIMUM REGISTRATION POLICY
Should the minimum enrollment number for the seminar not be met, EAS has the right to cancel by November 18, 2009, and refund the registration fee in full.
CANCELLATION POLICY:
Cancellations received two weeks before each seminar will result in a $95 processing fee. No refunds will be given for cancellations received after that date. Substitutions will be allowed as long as prior notice is given to EAS.
FOR MORE INFORMATION:
Contact Cathryn Sacra 703-684-4438 csacra@easconsultinggroup.com
