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Gain a comprehensive understanding in FDA compliance with current good manufacturing practices (cGMPs), as regulated and guided by national and international agencies for the pharmaceutical and industry. The course will emphasize the US FDA cGMPs and briefly touch on differences between the other regional markets in the rest of the world. In addition to pharmaceutical applications, nutritional supplements will also be discussed since this industry is held to standards very similar to therapeutics.
 
The goal of this course is to teach you how to apply the knowledge gained about GMP regulations to institutions that are either trying to develop clinical trial materials or commercial product for human or veterinary treatment to assure compliance. Teaching the foundation of current Good Manufacturing Practices and similar legislative edicts in other countries that are applied to Chemistry Manufacturing and Controls (CMC) in the biotechnology, pharmaceutical and nutritional supplement industries should provide that knowledge base.

Learning Objectives

  • Understand the FDA's basic Good Manufacturing Practices regulations

  • Understand the historical evolution of current Good Manufacturing Practices

  • Understand the regulatory structure of other countries that follow GMPs

  • Understand the application of guidance documents to the GMPs (ICH and FDA)

  • Develop a basic Quality Management System to manage GMPs

  • Use risk management tools in developing a compliance strategy

  • Respond with solutions to practical case studies as a learning tool.

 

Course Number: BIOL-40000
Credit: 3.00 unit(s)
Related Certificate Programs: Clinical Trials Design and ManagementQuality Assurance and ControlRegulatory Affairs Essentials

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