FSMA Supply Chain Programs for Dietary Supplement

On-Demand

Course Overview

Although dietary supplement manufacturers may be exempt from the preventative controls and supply chain program requirements of 21 CFR 117, raw material suppliers are not and many dietary supplement companies also manufacture products, such as meal replacements that are foods. These companies are not exempt and are required to have a written supply chain program as part of their food safety plan.

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

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.

Batch Production Record (BPR) and Master Manufacturing (MMR)

This course is 2.5-Hours. Join us for an interactive hands-on virtual training, designed to provide participants with practical tips to help improve efficiency in their MMR and BPR processes. This course is part of maintaining required compliance to 21 CFR 111 and provides opportunities for ongoing GMP training. Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, participants in this course will:
Take part in a collaborative online training developed to streamline the MMR development processes, focusing on:


Date: November 6, 2024 1:00 P.M to 3:30 P.M Eastern Time
Cost: $450.00

*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.