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Dietary Supplement GMP Training Course Description
A fast-rising public call for food and dietary supplements has resulted in a spell of companies making and marketing nutritional supplements in the United States of America, EU, and Canada. With the controlling authorities commencing to take a sturdier posture on implementation of controlling policies, events, and GMP compliance, it is significant for the businesses to confirm that their products fulfill the newest rules and necessities if they plan to market Complements in these countries.
This 2-day interactive simulated or online seminar will have a look at the regulations that affect Dietary Supplements in the USA, EU, and Canada. It will also discuss the ways to prove or authenticate that products are acquiescent to these rules. Differences in food and drug regulation in these countries will be noted too. We will also shelter what succeeds as a nutritional complement or dietetic element, ways to ensure GMP compliance as well as detailed requirements for labeling and acceptable marketing claims. An update on current events within the Addition manufacturing and the possible impacts on Manufacturers and Distributors in the US, EU, and Canada will also be presented and discussed.
Agenda
DAY 01(9:00 AM - 5:00 PM EDT)
Session Start Time: 9:00 AM
Dietary Supplement Regulation in the U.S.
▪ An Overview of Dietary Supplement
▪ What is a dietary supplement all about?
● Supplements vs.
● Pharmaceuticals
● OTC Drugs
● Conventional Foods
● Medical foods
● Natural products
● Herbal medicinal products
Organizations and Regulatory Structure
● FDA Assembly concerning Dietary Supplements
Industry Groups
History of Dietary Supplement Regulation
▪ Early History
▪ DSHEA
▪ Code of Federal Regulations
Manufacturing Considerations
▪ Company & Facility Registration
▪ GMP Requirements
▪ GMP inspections
Dietary Ingredients
▪ What qualifies as a dietary ingredient?
▪ New Dietary Ingredient Notification (NDIN)
▪ Old dietary ingredients vs. New dietary ingredients
▪ Updated New Dietary Ingredient Guidance from FDA
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
Advertising Considerations
▪ FDA vs. FTC jurisdiction
▪ Enforcement
▪ Expressed vs. Implied Claims
● Exercises & examples
▪ Disclosures
▪ Claim Substantiation
▪ Testimonials
DAY 02(9:00 AM - 5:00 PM EDT)
Food Supplement regulation in the EU
Overview
▪ What is a food supplement?
▪ Borderline products
▪ Medicinal Foods
Organizations and Regulatory Structure
▪ EU Regulatory Structure
▪ Industry Groups
Supplement Regulation
▪ Early History
▪ Food Supplement Directive
Manufacturing Considerations
▪ Company & Facility Registration
GMP Requirements
Dietary Ingredients
▪ What qualifies as a dietary ingredient?
▪ Ingredient safety
▪ RDA vs RDI
▪ DRV vs % Daily Value
Labeling Considerations
▪ Display Panels & Layout
▪ Labeling Claims
● Health claims
● Disease Claims
● Reduction of Disease Risk Claims
● Nutrition Claims
▪ Notification requirements
Advertising Considerations
▪ Enforcement
▪ Claim Substantiation
Natural Health Product regulation in Canada
Overview
▪ What is a Natural Health Product?
Organizations and Regulatory Structure
▪ Canadian Regulatory Structure
● Health Canada
● Canadian Health Products Directorate
Supplement Regulation
▪ National Health Products Regulation
▪ Differences between Canada and US
▪ Supplements monographs
▪ Requirements for pre-market approval
Manufacturing Requirements for Natural Health Products in Canada
Dietary Ingredients
Labeling Considerations
Advertising Considerations
Enforcement and Post-Marketing Surveillance
Review of Current Events and other Industry Topics Questions and Answers
Who are the possible beneficiaries?
▪ Sales/Marketing Employees in the Addition or Usual Product Industries
▪ Quality Control or Quality Assurance Professionals
▪ Controlling Compliance Professionals in the Supplements or Natural Products area
▪ Nutritional Addition or Natural Product Producers & Distributors
▪ Executives/Managers within Nutritional Supplement or Natural Product Companies
Faculty Travis Austin MacKay
Travis MacKay is the Director of Regulatory Affairs for Plexus Worldwide, a leading direct sales company with a range of products dedicated to helping others obtain health and happiness. He currently oversees international regulatory compliance activities driving strategic direction focused on claims development and substantiation strategy, product development and commercialization, international formulation considerations, and quality testing & validation.
Travis has 20 years of quality and regulatory experience, including prior regulatory affairs leadership positions within well-respected, global consumer product companies. He has a passion for mentoring regulatory professionals to develop robust compliance systems that keep business moving forward.