GMPs for Dietary Supplements: 21 CFR 111 Subparts E, K, F and J

On-Demand

$499.00Register

Course Overview

This self-paced course covers the requirements for specifications and guidance to establish them, which must be in place to ensure compliance with 21 CFR 111. Specifications for components, ingredients and in-process control points are critical to ensure finished product specifications are met.

This module also covers quality control responsibilities, laboratory requirements and guidance for conducting a root cause analysis and implementing effective corrective actions. The following subparts of 21 CFR 111 are reviewed:

  • Subpart E – Production and Process Control
  • Subpart K – Manufacturing Process Control
  • Subpart F – Quality Control
  • Subpart J – Laboratory Operations

View the Full Course Description

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: December 5, 2024 & December 6, 2024
Time: 1:00 P.M to 5:00 P.M Eastern Time

Cost: $900.00
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.

Virtual Classroom Training
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.