GMPs Part 111
This online course reviews 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. Course modules examine basic sanitary, production, process, and quality controls that are required for all 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 relevant to the production of dietary supplements.
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Students have 16 weeks to review course modules at their own pace. Modules cover the following topics: food safety; personnel; pest management; plant design; sanitary design of facilities, equipment and utensils; cleaning and sanitizing; production and process controls; quality control; written procedures; and record-keeping. Participants must complete and pass the quiz questions that are posted throughout the curriculum. After completing all of the modules and the quiz questions, students will receive a "Certificate of Course Completion" issued by the IFS@CU.
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 current GMP requirements.