Familiarity with the Good Manufacturing Practices (GMP) regulations is necessary for employees engaged in the manufacture, regulation, quality assurance, and control of drugs and biologics. Through lectures, discussions, and case studies, you’ll gain an understanding of the FDA GMP and Good Laboratory Practice (GLP) regulations. While primarily aimed at the manufacturing, quality control, and quality assurance worker, the course is also useful for regulatory affairs and clinical research professionals, as well as anyone who wants to understand which regulatory controls apply to the manufacture of drugs and biopharmaceuticals for human use.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At the conclusion of the course, you should be able to

• Understand how the GMP and GLP regulations affect the work environment in a pharmaceutical company.
• Develop an understanding of how GMP regulations are applied in daily operations, and why the regulations are considered necessary.
• While primarily aimed at the manufacturing or quality systems worker, the course should also help the regulatory or clinical affairs worker to understand what controls are expected during the manufacturing of all products for human use.
• As a general objective, the course will seek to have the student develop an understanding of why certain practices, attitudes, and environments exist within a mature pharmaceutical company.

Topics Include

• History, Regulation, Good Laboratory Practice
• General Provisions
• Control of Components and Drug Product Containers and Closures
• Biologics and Good Tissue Practice

Notes

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114, 30 hours.

The course will consist of four 6 hour sessions with a 45 minute lunch break and ~15 minute breaks every 1.5 hours.

The Instructor will provide the required text material in electronic format. By the end of the course, the student should have read the entity of the GMP regulations for drugs, biologics, and cell therapies. While the instructor may suggest the reading of guidance documents and other material, the GMPs will be the only required reading material.