Units
3.0 QUARTER UNITS
Estimated Cost
$875

Course Description


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.

Topics

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

Additional Information

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.

Professional Credit

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

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