The "Regulatory Compliance Mastery: Dietary Supplements in North America and Europe" training has been added to ResearchAndMarkets.com's offering.

If you are looking for training that is way beyond content-draining and one-sided seminars, this dietary supplement course is perfect for you. Whether you are a business owner or a manufacturing unit director, warning letters and injunctions are the last things you would wish for.

A nutraceutical product with quality as good as a pharmaceutical drug is possible when you apply the required GMP norms. Technological feasibility, safety, and cost efficiency are a few things to take into consideration when applying these GMP principles. This dietary supplement formulation training covers various instrumental topics to understand critical regulations. Get enrolled in this course and absorb all the useful insights related to the industry!

Course Overview

The main problem arises when manufacturers, distributors, and consumers don't understand the efficacy of dietary supplements. Due to a boom in the market, producers are coming up with supplements that are deficient.

Additionally, the ease of access and over-the-counter availability have diluted the importance of dietary supplements. This course is here to change the narrative and bridge the existing gaps.

Dietary supplement formulation training gives a comprehensive introduction to programming the entire manufacturing unit. Moreover, you will get to know the possible issues you might face while testing the products.

Here are some benefits of taking a course on regulatory compliance for dietary supplements:

• Understanding FDA expectations
• Knowing the rules and regulations to follow during the audits
• Improving the GMPs to upgrade operations in the unit
• Fundamentals of physical and chemical properties of the ingredients
• Stability studies and categorization
• Techniques to create a formulation that passes multiple checkpoints.

Who Should Attend:

• Quality testing and assurance: Helps them understand the basic parameters of testing the final product and by-products.
• In-house auditors: Assists them in doing strict audits to avoid product recalls and FDA inspection failures
• Suppliers and distributors: Makes them aware of licensing, marketing, and basic compliance related to dietary supplement distributions.
• Labelling and packaging: Labels play an essential role in maintaining transparency about the ingredients. Hence, one must give the highest priority to the norms associated with labeling and packaging. This course consists of 3 rounds of discussion on this topic.

Key Topics Covered:

United States

Overview

• An Overview of Dietary Supplements
• 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

Europe

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

Canada

Natural Health Product Regulation in Canada

• 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 the US
• Supplements monographs
• Requirements for pre-market approval

Manufacturing Requirements for Natural Health Products in Canada

• Dietary Ingredients
• Labelling Considerations
• Advertising Considerations
• Enforcement and Post-Marketing Surveillance
• Review of Current Events and Other Industry Topics
• Questions and Answers

Speakers:

Travis Austin MacKay

Plexus Worldwide

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.

Travis Graduated from the University of Utah in 2002 with a B.S. in Behavioral Science and Health (Human Health Emphasis). He is a fly-fishing enthusiast, a college football fan, an exercise junky, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.

For more information about this training visit https://www.researchandmarkets.com/r/cnv1r9

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