Method
Live-Online
Term
SUMMER
Units
3.0 QUARTER UNITS
Estimated Cost
$875

Skills you will gain

  • GMP & GLP Regulations: Understand the impact of FDA Good Manufacturing and Good Laboratory Practices on pharmaceutical operations.
  • Daily GMP Applications: Learn how GMP regulations are applied in everyday operations and their importance in maintaining quality.
  • Regulatory Controls in Manufacturing: Gain insight into regulatory controls and their role in drug and biopharmaceutical manufacturing.
  • Quality Assurance & Control: Develop a comprehensive understanding of quality systems in pharmaceutical production.
  • Industry Standards & Practices: Grasp why certain practices, attitudes, and environments are essential within a mature pharmaceutical company.

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.  
 

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
  • GMP requirements for Clinical Phases and Clinical Supply Manufacturing
  • Clinical Supply GMP release requirements US vs. EU
  • Biologics and Good Tissue Practice

 

Additional Information

The course will consist of nine 3.5 hour sessions with ~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 entirety 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.

Syllabus Library
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