Core Concepts of Biomanufacturing and Quality Systems (Live)

This course provides current or future 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 (CGMPs) 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

Individuals with at least some background in chemistry and biology who are interested in obtaining a basic understanding of large-scale biomanufacturing, which may include:

• New biomanufacturing employees
• Biomanufacturing support personnel who may not be directly involved with the process they support
• Vendors who supply the biomanufacturing industry with equipment and components
• Incumbent workers seeking to enter the biomanufacturing industry

Please contact Biotility to schedule this course.