Live Webinar
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Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA
Date & Time: Tuesday, February 21, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Robert J. Russell
Location: Online
Price : $245.00
Register Now
(for one participant)
Instructor Profile:
Overview:
Robert J. Russell President, RJR Consulting, Inc.
This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations.
For the past 9 years, Bob 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, 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. ...more
W e will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed. At the conclusion of this 75 minute presentation, there will be a 15 minute Q&A session with the speaker.
Areas Covered in the Session: l
Dietary Supplement Overview
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What is a dietary supplement? Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods Regulatory Structure
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FDA Structure regarding Dietary Supplements Industry Groups History of Dietary Supplement Regulation
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Early History & DSHEA Code of Federal Regulations Manufacturing Considerations ¡ Company & Facility Registration ¡
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¡ GMP Requirements 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 Labeling Considerations ¡ Display Panels & Layout ¡
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Supplement Facts Panel Requirements Labeling Claims n Health vs. Disease vs. Structure/Function claims n Disclaimers/Substantiation
Notification of labeling claims to FDA Dietary Supplement Labeling Act Advertising Considerations ¡ ¡
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FDA vs. FTC jurisdiction & enforcement Expressed vs. Implied Claims Disclosures & Claim Substantiation
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Click here to register for this webinar Who Will Benefit: l
Executives of Dietary Supplement companies
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Regulatory Compliance Professionals Quality Assurance Professionals Dietary Supplement Manufacturers
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Dietary Supplement Distributors Sales/Marketing Personnel
Your Necessity is our Priority
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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