GMPs for Dietary Supplements: 21 CFR 111 Subparts G, L, M, N, O and Compliance
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
ISO 22716: Good Manufacturing Practices for Cosmetic and Personal Care Professionals at Supply Side East
This course is 8-hours. The ISO 22716 GMP cosmetics training will show you how to identify regulatory non-compliances before they become an issue, minimizing risk while adding measurable value to the manufacturing process. This course has been updated with information from the U.S. FDA's draft guidance for cosmetics manufacturing, U.S. FDA's GMP Inspection Checklist for Cosmetics, and general requirements from the Modernization of Cosmetic Regulations Act (MoCRA) enacted in December 2022.
Learners will understand globally recognized ISO 22716 standards and the U.S. FDA’s draft guidance for cosmetics manufacturing.
This course is geared to those individuals involved in the cosmetics Industry including:
· Quality Control/Assurance
· Laboratory Operations
· Suppliers and Distributors
· Regulatory Affairs
· Product Development
· Brand Holders
Course Duration: 8 hours, delivered over 2 days
Day: April 30, 2024-May 1, 2024
Time: 1:00 P.M. to 5:00 P.M. Eastern Time
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 at Supply Side East
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
Duration of Class: 8 hours, delivered over 2 day
Date: May 6-7, 2024
Time: 1:00pm.-5:00pm Eastern Time
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.
Dietary Supplement Claims Substantiation at Supply Side East
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.
Course Duration: 6 hours
Date: May 3, 2024
Time: 11:00 AM to 5:00 PM Eastern Time
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.