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Natural Health Products Directorate

Seminar On Regulatory Compliance For Dietary Supplements In The US, EU And Canada At Boston

By John Ronbinson on August 03, 2012

This 2-day interactive live seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products are compliant with these regulations. Differences with food and drug regulation in these countries will be noted as well. We will also cover what qualifies as a dietary supplement or dietary ingredient, how to ensure GMP compliance as well as detailed requirements for labeling and acceptable marketing claims. An update on current events within the Supplement industry and the potential impacts to Manufacturers and Distributors in the US, EU and Canada will also be presented and discussed.

Course Outline: Day 1:

Dietary Supplement Regulation in the U.S.

Lecture 1: Dietary Supplement Overview

What is a dietary supplement?

Supplements vs.

Pharmaceuticals

OTC Drugs

Conventional Foods

Medical foods

Natural products

Herbal medicinal products

Lecture 2: Organizations and Regulatory Structure

FDA Structure regarding Dietary Supplements

Industry Groups

Lecture 3: History of Dietary Supplement Regulation

Early History

DSHEA

Code of Federal Regulations

Lecture 4: Manufacturing Considerations

Company & Facility Registration

GMP Requirements

GMP inspections

Lecture 5: 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

Lecture 6: Labeling Considerations

Display Panels & Layout

Supplement Facts Panel

Labeling Claims

Health claims

Disease Claims

Structure/Function claims

Disclaimers/Substantiation

Notification of labeling claims to FDA

Dietary Supplement Labeling Act

Lecture 7: Advertising Considerations

FDA vs. FTC jurisdiction

Enforcement

Expressed vs. Implied Claims

Exercises & examples

Disclosures

Claim Substantiation

Testimonials

Course Outline: Day 2:

Food Supplement regulation in the EU

Lecture 8: Overview

What is a food supplement?

Borderline products

Medicinal Foods

Lecture 9: Organizations and Regulatory Structure

EU Regulatory Structure

Industry Groups

Lecture 10: Supplement Regulation

Early History

Food Supplement Directive

Lecture 11: Manufacturing Considerations

Company & Facility Registration

GMP Requirements

Lecture 12: Dietary Ingredients

What qualifies as a dietary ingredient?

Ingredient safety

RDA vs RDI

DRV vs % Daily Value

Lecture 13: Labeling Considerations

Display Panels & Layout

Labeling Claims

Health claims

Disease Claims

Reduction of Disease Risk Claims

Nutrition Claims

Notification requirements

Lecture 14: Advertising Considerations

Enforcement

Claim Substantiation

Natural Health Product regulation in Canada

Lecture 15: Overview

What is a Natural Health Product?

Lecture 16: Organizations and Regulatory Structure

Canadian Regulatory Structure

Health Canada

Canadian Health Products Directorate

Lecture 17: Supplement Regulation

National Health Products Regulation

Differences between Canada and US

Supplements monographs

Requirements for pre-market approval

Lecture 18: Manufacturing Requirements for Natural Health Products in Canada

Lecture 19: Dietary Ingredients

Lecture 20: Labeling Considerations

Lecture 21: Advertising Considerations

Lecture 22: Enforcement and Post-Marketing Surveillance

Who Will Benefit:

Executives/Managers within Dietary Supplement or Natural Product companies

Regulatory Compliance Professionals in the Supplements or Natural Products area

Quality Assurance or Quality Control Professionals

Dietary Supplement or Natural Product Manufacturers & Distributors

Sales/Marketing Personnel in the Supplement or Natural Product Industries

GlobalCompliancePanel

www.globalcompliancepanel.com

support@globalcompliancepanel.com" target="_blank" rel="nofollow">support@globalcompliancepanel.com Click here for More Details Phone: 1800-447-9407
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Original article published on SooperArticles.com

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