Pills being dispensed in packing line

GMPs Part 111

Good Manufacturing Practices Part 111 for Dietary Supplements

GMPs Part 111

Please read the information on this page that describes what is covered in this new course, the intended audience, and how the course works before you register.

Course Overview

This Good Manufacturing Practices (GMPs) Online Course is designed to review the requirements of Part 111 – Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements in Title 21 of the U.S. Code of Federal Regulations. The regulation outlines the basic sanitary, production, process and quality controls that are required for all dietary supplement processing facilities, wholesale or distribution firms, and warehouses or storage facilities that manufacture, package, label, or hold FDA-regulated dietary supplements. The course also reviews sections of the Part 117, Subpart B – Current Good Manufacturing Practice under the FDA’s Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule that are relevant to the production of dietary supplements.

The course design provides the text of each section of the part 111 regulation, as well as the relevant sections of part 117, along with an explanation of the intent of each requirement, examples and strategies for compliance, and resources for additional information.

Register

Register for the course here.

Course Details

Compliance with Federal Regulations

The Certificate of Completion issued at the end of this online course can be used as a record to document that participants who completed the course received GMP training, including review of the principles of food hygiene and food safety as well as the importance of employee health and personal hygiene. Establishing and keeping records that document personnel training is required under both part 111 (21 CFR §111.14(b)(2)) and part 117 (21 CFR §117.4(d)).

Intended Audience

This course is intended for supervisors, middle-level managers, quality control personnel, and those responsible for ensuring that manufacturing, packaging, labeling, or holding dietary supplements meet the federal requirements for current GMPs.

Course Cost

The course fee is currently being offered at a discounted rate of $400 per person. Please contact Nancy Long at ifstraining [at] cornell.edu (ifstraining[at]cornell[dot]edu) for details regarding group registrations.

Important note: Refunds are not available after payment for the course is received.

How the Course Works

The course consists of 16 different modules:

  1. Course Logistics & Introduction to the CGMP Part 111 Regulation
  2. Food Safety: Microbes & Allergens
  3. Personnel: Health, Hygiene & Qualifications
  4. Pests, Plant Grounds & Pest Control
  5. Sanitary Facilities: Water, Plumbing & Waste Disposal
  6. Plant Design & Construction
  7. Equipment & Utensils
  8. Sanitary Operations: Cleaning & Sanitizing
  9. Establishing a Production and Process Control System & Quality Control Operations
  10. Laboratory Operations, Meeting Specifications, Material Reviews & Disposition Decisions
  11. Receiving
  12. Manufacturing Operations - Part 1
  13. Manufacturing Operations - Part 2
  14. Packaging, Labeling, Holding & Distributing
  15. Returned Dietary Supplements, Product Complaints, Records & Recordkeeping
  16. Building Written Procedures

Quizzes in each module will check your knowledge. Completing each quiz with a passing score of 100% is required to earn the Certificate of Course Completion, as described below.
 

Course Registration

The registration steps are as follows:

  1. Complete the IFS@CU course registration web form;
  2. Pay for the course; and
  3. Create an account to access the online course.

Instructions to complete step 2 and 3 will be sent to each participant via email after completion of step 1. After completing all 3 steps outlined above each student will be notified that they have been enrolled into the online course. Students will have 16 weeks to complete the course from the date of enrollment. All communications related to this course will be by email, and each student must have a working email address to participate. 

Important note: Refunds are not available after payment for the course is received.
 

System Requirements

The course material is accessed through a browser such as Safari, Chrome, Firefox or Edge. For best results please make sure you're using the most current version of your browser software by installing any needed updates. The software application for the online delivery of the course requires one of the following operating systems: Windows 7 and newer; Mac OSX 10.10 and newer; or Linux – chromeOS.

Course Completion Certificate

Students will earn a “Certificate of Course Completion” after passing each quiz with a score of 100%. Course certificates are issued weekly and emailed to students on Friday mornings during IFS@CU business hours. This certificate will be issued to the individual person who registered for the course, and will contain the date of completion. The certificate should be kept on file to show that this individual has received training on GMP regulations, including food safety, personal health and hygiene.

Frequently Asked Questions

I am having a problem accessing the course. What should I do?

Please contact Nancy Long (ifstraining [at] cornell.edu (ifstraining[at]cornell[dot]edu)) and she will assist you with gaining access to the course.

Is the course offered in Spanish?

Unfortunately at this time, the GMPs Part 111 Online Course is not offered in Spanish.

I completed the course. How can I get my Certificate of Completion?

Certificates of Completion are issued weekly on Friday mornings during business operations. For questions, please contact Nancy Long (ifstraining [at] cornell.edu (ifstraining[at]cornell[dot]edu)). Please note, we sometimes adjust the schedule for University or office closures, but will give enrolled participants advanced notice through announcements in Canvas.

Can I have an extension to complete the course?

Participants have 16 weeks to complete the course from the time of payment. If you need additional time to complete the course, please email Nancy Long (ifstraining [at] cornell.edu (ifstraining[at]cornell[dot]edu)) to request a one-time extension. Please note that we do not grant participants unlimited access to the course.

I paid for the course, but now I don’t need to take it. How do I get a refund for the course?

Unfortunately, refunds are not available after payment for the course is received.

Will my dietary supplement be GMP certified after completing this course?

No, completing this course will not provide a GMP certification of your product or firm. The course is intended to provide training on meeting the federal regulations for good manufacturing practices of dietary supplements under 21 CFR Part 111. GMP certification is obtained by working with a third party audit firm. Working with a third party audit firm to obtain GMP certification may be necessary to fulfill some buyer requirements, but is not necessary to meet federal regulatory requirements.