FSMA Supply Chain Programs for Dietary Supplement
On-Demand
Course Overview
In this one-hour pre-recorded session we highlight the key requirements of 21 CFR 117 subpart G that are required for all raw material suppliers and any manufacturer that makes a product with a Nutrition Facts label. You will learn what the FSMA based supply chain programs have in common and differ from the supplier qualification requirements of 21 CFR 111, as well as what you and your raw material suppliers need to do to be compliant with this part of the regulation.
Learning Objectives:
- Understand what the components of a supply chain program
- Know where to find the new regulations
- Recognize the difference in supplier qualification requirements under 21 CFR 111 and 21 CFR 117 Subpart G
- Know what is required for supplier audits
Additional Recommended Courses
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: August 8, 2024 & August 9, 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.
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.