GMPs Part 117
This Good Manufacturing Practices (GMPs) Internet Course is designed to review the requirements of Part 117 Subpart B – Current Good Manufacturing Practice in Title 21 of the U.S. Code of Federal Regulations Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. As part of the FDA's Food Safety Modernization Act (FSMA), several revisions were made to the current GMPs regulation to update and clarify it. The regulation outlines the basic sanitary controls that are required for all food processing plants, wholesale or distribution firms, and warehouses or food storage facilities that handle, store or process FDA regulated food.
This course provides the text of each section of this regulation (21 CFR Part 117 Subpart B) along with an explanation of its intent, examples and strategies for compliance with these new requirements as well as resources for additional information.
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 training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene (21 CFR §117.4(b)(2)). Establishing and maintaining this record is a requirement in 21 CFR §117.4(d).
This course does NOT meet the regulatory requirements for becoming a "preventive controls qualified individual (PCQI)." The Food Safety Preventive Controls Alliance (FSPCA) developed a course that is a “standardized curriculum” recognized by FDA and successfully completing that course is one way to meet the requirements for a “preventive controls qualified individual (PCQI).” Visit the FSPCA's website for more information on when and where the next PCQI training will be held.
This course was designed for supervisors, middle level managers, quality control personnel and anyone else who has responsibilities for ensuring that a food processing, wholesale and warehouse operation meets current GMPs requirements.
The course fee is $200. Group discounts are available for groups with 20 or more participants. Please contact Nancy Long at ifstraining [at] cornell.edu for details. Please note that refunds are not available after payment for the course is received.
How the Course Works
The course consists of 12 different Modules:
- GMP Regulation & Training
- Food Safety: Microbes & Allergens
- Personnel: Health & Hygiene
- Plant Grounds & Pest Control
- Plant Construction & Design
- Sanitary Facilities: Water, Plumbing & Toilets
- Sanitary Operations: Cleaning & Sanitizing
- Equipment & Utensils
- Plant Operations & Raw Materials
- Manufacturing Operations: Process Controls
- Warehousing, Food Disposition & Defects
- Building Sanitation Procedures
Each module concludes with a quiz to test your knowledge. Completing each quiz is required to receive the Certificate of Course Completion, as described below.
The registration steps are as follows:
- Complete the IFS@CU course registration web form;
- Pay for the course; and
- 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 12 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. Please note that refunds are not available after payment for the course is received.
The course material is accessed through a browser such as Safari, Chrome or Internet Explorer. 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
When answers to the quiz questions for all 12 modules have been submitted, the student will receive a “Certificate of Course Completion” by email to demonstrate that they have completed this GMP internet training course. 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.