2024 - Regulatory Compliance Mastery: Dietary Supplements in North America and Europe

Dietary Supplements Course Description
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.
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.
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.
At World Compliance Seminar, we want to equip you with the best knowledge to pursue your career progressively. The detailed seminar is divided into two days and the first day consists of dietary supplements regulation in the US. As a result, the session will cover the following topics:
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
Labelling Considerations
Display Panels & Layout
Supplement Facts Panel
Labelling 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
The second day of the seminar covers the food supplement regulations in the EU. Hence, the topics discussed are:
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
· 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
Labelling Considerations
Advertising Considerations
Enforcement and Post-Marketing Surveillance
Review of Current Events and other Industry Topics
Questions and Answers
Who will benefit from the course?
The course is designed to benefit professionals associated with different departments of dietary supplement manufacturing units, such as:
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.