Overview course that examines the basics of current good manufacturing practice (cGMP) in the pharmaceutical industry. This course also addresses U.S. Food and Drug Administration regulations that govern cGMP as well as other applicable industry and international standards.
Explores the FDA regulation “Good Laboratory Practice for Nonclinical Studies” (21 CFR 58) as well as applicable EPA regulations (40 CFR 160 and 40 CFR 792) and OECD principles, the international counterpart to U.S. regulations.
Examines the cGMP personnel responsibilities, qualifications, and requirements of personnel as well as key personnel involved in pharmaceutical manufacturing.
Defines validation and other terms used in the validation process. This course reviews the regulations and discusses the newest FDA guidelines, giving a more detailed review of what is recommended at each of the three stages of validation (process design, process qualification, and continued process verification).
Discusses how to create and maintain cGMP-compliant records. This course emphasizes the importance of good documentation and discusses the four-tiered document system recommended for cGMP facilities, including a review of the documents and their contents (as required by the FDA in 21 CFR 211, Subpart J).
Discusses the importance of having, understanding, and following standard operating procedures (SOPs). This course reviews the content of an SOP, discusses time-tested tips for effective writing of SOPs, gives an overview of the SOPs required by cGMP regulations, and explains the steps in an SOP management process.
Examines current Good Manufacturing Practice for buildings, facilities, and equipment involved in the manufacture of pharmaceutical products.
Examines the different types of materials utilized in pharmaceutical manufacturing and how they are controlled and regulated.
Explores current Good Manufacturing Practice for sanitation and hygiene in pharmaceutical manufacturing as it applies to personnel, facilities, equipment, materials, and containers.
Explores the manufacture of sterile pharmaceutical products, including general requirements, sterile production guidelines, and sterile preparations.
Discusses the quality system approach to cGMP, including major terms, concepts, best practices, and FDA requirements.
Examines the complaint and recall process involving pharmaceutical products in distribution by looking at the investigation that takes place when a complaint is filed and the reasons for a recall.
Examines self-inspections conducted by drug manufacturing facilities and external audits conducted by the FDA. Topics include the purpose, scope and frequency of formal self-inspections, as well as quality unit audits, frequency and triggers for external FDA audits, and the FDA’s six-system inspection model.
Addresses job competencies and the need for training in the pharmaceutical manufacturing industry. Topics include employee requirements, training triggers, technical training and evaluation, training reports, and specific training.
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.
Reviews the major hazards to food safety that cGMPs protect against. Topics include natural toxins, molds, microorganisms, pests, allergens, chemicals, and physical contaminants.
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.
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.
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.
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.