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Top 10 Audit Findings and Ways to Get a Warning Letter

On-Demand

Course Overview

In this one-hour course, we will discuss the latest trends in FDA observations during their inspections of dietary supplement manufacturers. Discuss the top ten items that manufacturers are cited for, to help you in mitigating your risk and identifying non-conformances ahead of time. At the conclusion of this training participants will have an understanding of:
  • How to use the Code of Federal Regulations, pharmacopoeias and guidance documents as source information.
  • Who is the FDA and what power do they have?
  • How the FDA communicates with the company and how you should communicate with the FDA.
  • The top 10 items that dietary supplements manufacturers are cited for and — most importantly — the steps you can take to avoid each one of them!

Additional Recommended Courses

Dietary Supplement Labeling and Compliance

It is up to dietary supplement manufacturers to ensure their supplement labels are compliant before they go to market, however the regulations can be confusing and difficult to interpret. Label noncompliance can cause your product to be considered misbranded and subject to Food & Drug Administration regulatory action.

Learn about the regulations that govern dietary supplement labeling including what can be considered a dietary supplement.

· Label compliance/noncompliance

· Regulations that govern dietary supplement

· Supplement Facts formatting

· Ingredient Lists

· Permitted claims, enforcement/litigation trends

· Adverse Event Reporting.

· The Regulatory Background and Enforcement

· Mandatory Label Elements

· Voluntary Label Elements

· How to apply the FTC and FDA regulations

· Define dietary supplement

Day 1: November 7, 2024 - 1:00 PM to 4:00 PM Eastern Time

Day 2: November 8, 2024 - 1:00 PM to 4:00 PM Eastern Time

Cost: $700.00

*Register 3 or more attendees from the same company and receive a 10% discount off each registration*

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time

Virtual Classroom Training
21 CFR 111 Dietary Supplement GMP Overview

This training course is 16-Hours split over 3-days. FDA expects all companies that manufacture, package, or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement CGMPs. This course provides a basic understanding of CGMPs and the responsibilities expected for various individuals and groups within the company. Participants will learn how to apply CGMP principles to specific situations. The course is interactive, with hands-on exercises including case-studies from recent Warning Letters.


As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Course Prerequisites: None

Date: November 13, 2024

Time: 12:00 pm to 5:00 pm Eastern Time

Date: November 14, 2024

Time: 12:00 pm to 5:00 pm Eastern Time

Date: November 15, 2024

Time: 12:00 pm to 6:00 pm Eastern Time

Cost: General Registration $1200.00

*Register 3 or more attendees from the same company and receive a 10% discount off each registration*

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Virtual Classroom Training
Dietary Supplement Claims Substantiation

This course is 6-Hours. The labeling and promotion of your dietary supplement products are the most visible ways that the Food & Drug Administration and the Federal Trade Commission can track your compliance with federal regulations. A perfect complement to “Dietary Supplement Labeling Compliance”, this course will go over in detail each type of permitted claim that is available to you and the criteria for making each one. We will cover FDA and FTC standards for substantiation, how to build the substantiation for each claim that the FDA and FTC requires you to hold to ensure your claims are accurate and not misleading, and how you can avoid making implied claims which could lead to regulatory enforcement.
Participants will learn how public knowledge of FTC and FDA enforcement actions affect business performance, enforcement/litigation trends and other responsibilities of dietary supplement manufacturers such as structure/function claim notification.


Day: December 12, 2024 & December 13, 2024

Time: 1:00 PM to 4:00 PM Eastern Time Both Days

Cost: $600.00

*Register 3 or more attendees from the same company and receive a 10% discount off each registration*
Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Virtual Classroom Training