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
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.
NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplement
The purpose of this training is to understand the requirements for the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplement Standard and how to implement them at your facility. The standard is based on 21 CFR 111 requirements, other regulations (normative references), retailer criteria, and industry best practices. The criteria in this standard were structured to follow a seven (7) systems approach. In this training we will discuss what you will need to prepare in preparation for an audit at your dietary supplement manufacturing facility.
We will not be discussing the need for documented procedures and evidentiary records in depth as this is well documented within the standard as well as the prerequisite Dietary Supplement GMP Training and is always best practice.
The training is divided into two sections:
Section 1
- Context of the organization- this includes requirements for implementing a quality management system (QMS) as well as regulatory requirements.
- Leadership- this includes requirements for management to demonstrate commitment to the QMS, such as assigning roles and responsibilities throughout the organization.
- Planning, which includes requirements for planning for the ongoing function of the QMS.
Section 2
- Support - includes requirements for management of resources for the QMS. This includes buildings and infrastructure, human resources, and control of documents.
- Operation - includes requirements on planning and creating of the product.
- Performance evaluation - includes requirements for monitoring the QMS and evaluation of the product.
- Improvement - includes requirements for taking corrective action for product or process nonconformities, and actions to make the QMS better over time.
Key Learning Objectives
- You will learn the structure of the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplements Standard, with a detailed overview of each section of the standard.
- You will learn the specific requirements of the NSF/ANSI 455-2-2024 Good Manufacturing Practice for Dietary Supplements Standard.
- You will understand the intent of the required programs and elements of the 455-2 standard from the NSF/ANSI 455-2- ARG - Audit Requirements Guidance for Good Manufacturing Practices for Dietary Supplements.
- You will learn best practices on how to implement the required programs and elements of the standard.
- You will learn what documentation is necessary to demonstrate compliance with the standard at your facility.
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
Dates: May 21-23, 2025
Time: 1:00 P.M to 5:00 P.M Eastern Time
Cost: $1000.00
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.
Vendor Qualification and Audit Virtual SupplySide Connect New Jersey Training
Description:
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: March 24, 2025 1:00pm-5:00pm Eastern Time
Day 2: March 25, 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.