Current Good Manufacturing Practice is a regulatory prescription for producing drug products that are safe for humans and animals. In the United States, the Food and Drug Administration (FDA) requires pharmaceutical manufacturers and companies that conduct Phase III clinical trials to comply with cGMP regulations.
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Overview course for current Good Manufacturing Practice (cGMP) for the food industry in the United States. Topics include cGMP regulations, specifically 21 CFR 110; regulatory authorities; the Codex Alimentarius; and other programs and standards of food safety, including HACCP and the Food Codes. This course also examines modernization efforts targeting the food cGMP regulation. (25 min)
Reviews the major hazards to food safety that cGMP protect against. Topics include natural toxins, molds, microorganisms, pests, allergens, chemicals, and physical contaminants. (50 min)
Examines the provisions of 21 CFR 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food with regard to personnel hygiene, sanitary operations, and pest control in food manufacturing plants. (30 min)
Examines the regulatory requirements for the design, construction, and maintenance of a food manufacturing plant and its grounds. This course also examines equipment and utensils used in the plant as well as the plant’s sanitary facilities and controls. (30 min)
Reviews the cGMP requirements for raw materials, manufacturing operations, warehousing, and distribution (including proposals for modernization of the regulations). This course also reviews Quality Control in a food processing facility. (35 min)
Examines recalls and traceability in the food manufacturing industry. Recall topics include types of recalls, action levels, roles of agencies, recall plans, and plan evaluation. The course also discusses traceability, including its purpose, definition, and methods. (35 min)
Explains which records fall under 21 CFR Part 11 (also known as Part 11), the characteristics that electronic records must have to be acceptable, and how to control computer systems used to manage electronic records. The course also discusses the types of electronic signatures that are acceptable and the safeguards that must be used so that they will be non-refutable. (30 min)