Top 10 Audit Findings and Ways to Get a Warning Letter
On-Demand
Course Overview
- 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
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.
Internal Auditing Training for Dietary Supplement
This course is 8-Hours. This dietary supplement internal auditing course will help you understand the fundamentals of auditing and how to conduct an internal audit focused on cGMP and other FDA requirements. The training incorporates internal audit best practices, regulatory requirements and information on turning internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA are incorporated into the content.
You’ll learn how to prepare, perform, report and close an audit and discuss the importance of using CAPA systems as a follow-up to your internal audit findings.
Part 1 - October 17, 2024 1:00pm.-5:00pm Eastern Time
Part 2 - October 18, 2024 1:00pm-5:00pm Eastern Time
Cost: $600.00
*Register 3 or more attendees from the same company under the "General Registration" type, 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.