Good Manufacturing Practices (cGMP)

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.

When paired with ExxTend Learning™, OverNite Software’s dynamic information and training delivery and management system, these online courses can be delivered efficiently and quickly to your team. This versatile learning management system includes everything needed to administer your company’s training needs, including student registration and tracking, testing and reporting, curriculum and course administration — all accessible to users and administrators through a 100% Web interface. ExxTend Learning™ is also backed by a topnotch technical support team.

280 Introduction to Food Current Good Manufacturing Practice (cGMP)

Introduction to Food Current Good Manufacturing
Practice (Food cGMP) discusses cGMP regulations,
specifically 21 CFR 117 and its provisions; regulatory
authorities, the Food Codes, and other programs and
standards of safe food manufacturing, including
HACCP and HARPC (food plan).

281 Food cGMP: Hazards to Food Safety

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)

282 Food cGMP: Hygiene and Sanitary Operations

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)

283 Food cGMP: Building, Facilities, and Equipment

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)

284 Food cGMP: Production and Process Controls

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)

285 Food cGMP: Recalls and Traceability

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)

259 Electronic Records, Electronic Signatures

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)