Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs

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This 2-day 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 process, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release 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


Live courses are currently suspended due to COVID-19.

Course Features

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