21 CFR 111 Dietary Supplement GMP Overview
About This Course
FDA expects all companies that manufacture, package or hold dietary supplement products to follow 21 CFR 111, the Dietary Supplement current Good Manufacturing Practices (cGMPs). Combining extensive industry experience and concrete understanding of regulations with flexible and convenient training, this course provides a solid understanding of cGMPs and the responsibilities expected for various individuals and groups within the company. You will learn how to apply cGMP principles to specific situations.
The 21 CFR 111 GMP training is interactive, with hands-on exercises including case studies from recent warning letters. Bring your questions and prepare to interact with the instructor and your peers in the industry.
This dietary supplement GMP training course provides an overview of subparts A-P of the 21 CFR 111 regulation, including:
- Specifications
- Master manufacturing records/batch production records (MMR/BPR)
- Quality and FDA authority
- Warning letters
- How to make sense of complex regulations in an understandable and comprehensive manner
- How to effectively convert regulations into real-world examples and scenarios, offering clarity and operational success
- How regulations can be applied to your organization in a cost-effective manner
Key Learning Objectives
At the end of this course, you will understand the following:
- Basic requirements of the cGMPs
- Details of cGMPs as they relate to:
- Personnel
- Buildings and facilities
- Equipment
- Facility records
- Production and process control
- Holding and distribution
- Batch records
- Packaging and labeling
- Quality control and quality assurance
- Laboratory operations
- Product complaints
- The purpose of guidance documents
- 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.
Who Should Attend?
Attend this training if you work in:
- Management
- Manufacturing
- Quality control/assurance
- Packaging
- Marketing
- Laboratory operations
- Auditing
- Suppliers and distributors
- Regulatory affairs
Instructors
Course instructors will be selected from the following:
Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation such as SOPs and WIs and has completed root cause investigations, CAPAs and complaints for corporate clients.
Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.
Shawn Ludlow - Shawn Ludlow is a well-established NSF GMP instructor. He has created several third-party certified quality programs compliant with 21 CFR 111, ISO 9001:2000 and FAMI–QS.
With an undergraduate degree in chemistry, master’s degree in public health and experience working as an analytical chemist for several years , Shawn found his education and work experience combination to be a natural fit for dietary supplement manufacturers looking to improve their quality programs.
Can’t Attend the Live Course?
Additional Recommended Courses
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.
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 - November 13, 2025 1:00pm-5:00pm Eastern Time
Part 2 - November 14, 2025 1:00pm-5:00pm Eastern Time
Cost: $800.00
*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.