Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs

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Created in response to industry demand for employees who understand the practices and nuances of working in a regulated industry, this course provides future or current employees a comprehensive and applied understanding of how regulatory compliance is built into all aspects of a company.  Using a blend of hands-on applications and lectures, course instructors integrate current Good Manufacturing Practices with core concepts of the manufacturing processes, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release-for-sale of a regulated product.


  • Identify primary aspects of regulatory compliance with respect to departmental roles and responsibilities
  • Gain a working knowledge of cGMPs and the relationship between compliance and risk management
  • Apply cGMPs to the manufacture, testing, and release for sale of a regulated product
  • Demonstrate the use of industry-specific documentation to meet cGMP requirements
  • Understand the correlation of facility, equipment, and process control via qualification and validation



This course is temporarily unavailable, as we await the completion of our new facility. New dates will be posted as soon as they are available.  Please contact Harry Rambo for more information.

Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 16 hours
  • Skill level All Levels
  • Wet Lab Yes
  • Max Students 16
  • Assessments Yes