Training Course Syllabus:

Course Description
This course will show the FDA’s requirements for dietary supplement manufacturing and teach how to implement the concepts in a plant and manage the compliance requirements using the quality management system approach.

This course will present the following.

GMP requirements for dietary supplement manufacturers.
The FDA’s interpretation of 21 CFR Part 111 GMP requirements.
How to develop a Quality Management System for implementing the GMP requirements.
How to implement a Quality Management System for compliance to the FDA GMP requirements.
How to manage the Quality Management System.
The roles and skill sets required for plant personnel to successfully develop, implement and manage a Quality Management System.
Personnel interactions required to develop, implement and manage a Quality Management System.

Learning Objectives:

GMP requirements for dietary supplement manufacturers.
Know where to find the GMP requirements
Understand the GMP requirements
The FDA’s interpretation of 21 CFR Part 111 GMP requirements.
Understand the purpose of the preamble
Learn how to use the preamble
Quality Management Systems
How to develop a Quality Management System for implementing the GMP requirements.
Understand what a Quality Management System is
Understand what should be in a Quality Management System
How to develop a Quality Management System
Learn to implement a Quality Management System for compliance to FDA GMP requirements.
Learn to manage the Quality Management System.
Learn about the roles and skill sets required for plant personnel to successfully develop, implement and manage a Quality Management System.
Learn about the Personnel interactions required to develop, implement and manage a Quality Management System.

Topic Background:

The FDA gives guidance to dietary supplements manufacturers through 21 CFR Part 111. A thorough understanding of the regulations and their interpretation by the FDA is necessary to apply the requirements in a plant. The application of the regulations requires developing processes and procedures.

The FDA’s 21 CFR Part 111 is a list of specific Good Manufacturing Practice (GMP) requirements for how dietary supplements should be manufactured, packaged, labeled and held. The FDA publishes the preamble to 21 CFR Part 111 as a companion to the GMP requirements. The preamble is the FDA’s interpretations of its GMP requirements. It is the FDA’s responses to questions submitted about the requirements.

The GMP requirements can be applied in a using a Quality Management System (QMS) approach. A QMS is a list of procedures and policies that translates the GMP requirements to a set of executable processes. Understanding the FDA’s interpretation of the GMP’s is important in helping plants develop their processes and procedures. Processes and procedures and how they are executed by plant personnel are important in determining whether compliance to the FDA’s GMP requirements will be achieved. Processes and procedures need to be simple and direct. The roles and responsibilities of plant personnel and their interactions with the QMS are also important and need to be clearly defined.

Seminar Summary:

This course will show the FDA’s requirements for dietary supplement manufacturing and teach how to implement the concepts in a plant and manage the compliance requirements using the quality management system approach. (see full course description)

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