GMPs for Dietary Supplements: 21 CFR 111 Subparts G, L, M, N, O and Compliance
On-Demand
Course Overview
This self-paced course covers the requirements for dietary supplement packaging and labeling systems, applicable even if these are the only operations at your facility. Also covered in this module are the requirements for warehousing and distribution of dietary supplements and the FDA regulations for procedures involving product complaints and returns. The following subparts of 21 CFR 111 are covered:
- Subpart G - Components, Packaging and Label Control
- Subpart L - Packaging and Labeling Control System
- Subpart M - Holding and Distributing
- Subpart N - Returns
- Subpart O - Complaints
This module also reviews what to expect during an FDA inspection and how to be prepared for one.
Additional Recommended Courses
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: December 10, 2025
Time: 12:00 pm to 5:00 pm Eastern Time
Date: December 11, 2025
Time: 12:00 pm to 5:00 pm Eastern Time
Date: December 12, 2025
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.
Vendor Qualification and Audit Training
Vendor Qualification and Audit Training
Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. But FDA does not provide much guidance on how to qualify vendors. This class is designed for to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers. Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. The auditing skills and techniques learned in this course are independent of the type of auditing or the standard being audited. These skills and techniques will be useful when conducting internal audits as well as performing audits of suppliers
Day 1: September 18, 2025 1:00pm-5:00pm Eastern Time
Day 2: September 19, 2025 1:00pm-5:00pm Eastern Time
Cost: $800.00
Completion of the course means being in attendance 95% of the log in time. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
21 CFR 111 Dietary Supplement GMP Overview - Intro
This course provides an overview of 21 cCFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and describe the purpose of GMP rules, regulations and FDA enforcement.
o Personnel
o Buildings and Facilities
o Equipment
o Facility Records
o Production and Process Control
o Holding and Distribution
o Batch Records
o Packaging and Labeling
o Quality Control and Quality Assurance
o Laboratory Operations
o Product Complaints
· The role of the FDA and their authority
· The roles and responsibilities of the Quality Unit
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Dates: January 30 and January 31st, 2025
Time: 1:00 P.M to 5:00 P.M Eastern Time
Cost: $800.00
Course Prerequisites: None
*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.