RAPS pre-approved webinar on "Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA" from GlobalCompliancePanel
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA" on October 9.
- Washington, DC-MD-VA-WV (1888PressRelease) October 09, 2012 - The demand for dietary supplements has gone up exponentially in the last few years, and has become even more pronounced following the passage in 1994 of the Dietary Supplement Health and Education Act. Their nutritive value combines with a relatively easier premarket approval process from the FDA to create a high demand for them.
As a result, more and more companies are making a beeline to get a piece of the pie. As more and more companies have entered the fray with their own preparations; the FDA has tightened the noose on dietary supplement enforcement, making it mandatory for companies to have their products comply with regulations.
This webinar will familiarize participants with knowledge and techniques relating to dietary supplements. It will impart to them ways by which they can verify if a particular product is compliant or not. It will also talk about what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims.
Apart from making an overview of the differences between existing food and drug regulations; this webinar will offer an update on FDA's draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011).
These are the areas it covers:
o Dietary Supplement Overview
What is a dietary supplement?
Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods
Regulatory Structure
o FDA Structure regarding Dietary Supplements
Industry Groups
o History of Dietary Supplement Regulation
Early History & DSHEA
Code of Federal Regulations
o Manufacturing Considerations
Company & Facility Registration
GMP Requirements
o Dietary Ingredients
What qualifies as a dietary ingredient?
Old dietary ingredients vs. New dietary ingredients
New Dietary Ingredient Notification (NDIN)
Updated New Dietary Ingredient Guidance from FDA
o Labeling Considerations
Display Panels & Layout
Supplement Facts Panel Requirements
Labeling Claims
Health vs. Disease vs. Structure/Function claims
Disclaimers/Substantiation
Notification of labeling claims to FDA
Dietary Supplement Labeling Act
o Advertising Considerations
FDA vs. FTC jurisdiction & enforcement
Expressed vs. Implied Claims
Disclosures & Claim Substantiation
Testimonials
When: October 9, 10:00 AM PDT | 01:00 PM EDT
By whom: For the past nine years, Robert J. Russell has been President of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington DC, and Brussels, Belgium with exclusive affiliates across Asia and Latin America.
Bob has 28 years of past industry experience as a CMC specialist, R&D Director and Global Director of Regulatory Affairs for Merion Merrill Dow pharmaceuticals and Cordis-Dow medical devices. He has a BS/MS degree in Chemistry.
For whom:
The webinar will benefit
o Executives of Dietary Supplement companies
o Regulatory Compliance Professionals
o Quality Assurance Professionals
o Dietary Supplement Manufacturers
o Dietary Supplement Distributors
o Sales/Marketing Personnel
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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